Completeness Criteria for Retrieval in Recommender Systems
学名药使用者付费修正案对於第二类原料药主档案之完整性评估审查
Center for Biologics Evaluation and Research (CBER)
October 2017
Pharmaceutical Quality/CMC/Generics
Revision 1
Check of Completeness Assessment Elements............................................................................. 4
API INFORMATION INCLUDED IN A GENERIC DRUG SUBMISSION............. 6
Pharmaceutical Quality/CMC/Generics
Revision 1
Contains Nonbinding Recommendations TABLE OF CONTENTS
I. II. III.
B.
INTRODUCTION............................................................................................................. 1
or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
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优秀病历评比系列活动方案
优秀病历评比系列活动方案English response:Goal: To establish a comprehensive program for evaluating and recognizing clinical excellence in patient documentation.Objectives:To promote the use of standardized, high-quality documentation practices that enhance patient care and communication.To identify and reward healthcare professionals who demonstrate exceptional skills in clinical documentation.To foster a culture of continuous quality improvement in the healthcare setting.Implementation:Establishment of a Review Committee: A multidisciplinary committee will be formed to establish criteria for evaluating clinical documentation and to conduct the review process.Development of Evaluation Criteria: The committee will develop objective, evidence-based criteria for assessing the accuracy, completeness, organization, and clarity of clinical documentation.Solicitation of Nominations: Nominations for优秀病历评比系列活动 will be sought from healthcare professionals, patients, and other stakeholders.Review Process: The committee will review nominated clinical documents using the established criteria.Selection of Winners: The committee will selectthe top-scoring clinical documents for recognition.Recognition and Dissemination: Winners will be recognized through various channels, including awards, presentations, and publications. Best practices identified during the review process will be shared with thehealthcare community.中文回答：优秀病历评比系列活动方案。
审计学-一种整合方法阿伦斯英文版第12版课后答案解析Chapter22SolutionsManual
Chapter 22Audit of the Capital Acquisition and RepaymentCycleReview Questions22-1Four examples of interest bearing liability accounts commonly found on balance sheets are:1. Notes payable2. Contracts payable3. Mortgages payable4. Bonds payableThese liabilities have the following characteristics in common:1. Relatively few transactions affect the account balance, buteach transaction is often highly material in amount.2. The exclusion of a single transaction could be material in itself.3. There is a legal relationship between the client entity and theholder of the stock, bond, or similar ownership document.4. There is a direct relationship between interest and dividendaccounts and debt and equity.These liabilities differ in what they represent and the nature of their respective liabilities.22-2The characteristics of the liability accounts in the capital acquisition and repayment cycle that result in a different auditing approach than the approach followed in the audit of accounts payable are:1. Relatively few transactions affect the account balance, buteach transaction is often highly material in amount.2. The exclusion of a single transaction could be material in itself.3. There is a legal relationship between the client entity and theholder of the stock, bond, or similar ownership document. 4. There is a direct relationship between interest and dividendaccounts and debt and equity.22-3It is common to audit the balance in notes payable in conjunction with the audit of interest expense and interest payable because it minimizes the verification time and reduces the likelihood of overlooking misstatements in the balance. Once the auditor is satisfied with the balance in notes payable and the related interest rates and due dates for each note, it is easy to test the accuracy of accrued interest. If the interest expense for the year is also tested at the same time, the likelihood of omitting a note from notes payable for which interest has been paid is minimized. When there are a large number of notes or a large number of transactions during the year, it is usually too time consuming to completely tie out interest expense as a part of the audit of the notes payable and related accrued interest. Normally, however, there are only a few notes and few transactions during the year.22-4The most important controls the auditor should be concerned about in the audit of notes payable are:1. The proper authorization for the issuance of new notes (orrenewals) to insure that the company is not being committedto debt arrangements that are not authorized.2. Controls over the repayment of principal and interest to insurethat the proper amounts are paid.3. Proper records and procedures to insure that all amounts inall transactions are properly recorded.4. Periodic independent verification to insure that all the controlsover notes payable are working.22-5The most important analytical procedures used to verify notes payable is a test of interest expense. By the use of this test, auditors can uncover misstatements in interest calculations or possible unrecorded notes payable.22-6It is more important to search for unrecorded notes payable than unrecorded notes receivable because the omission of an asset is less likely to occur than the omission of a debt. Several audit procedures the auditor can use to uncover unrecorded notes payable are:1. Examine the notes paid after year-end to determine whetherthey were liabilities at the balance sheet date.2. Obtain a standard bank confirmation that includes specificreference to the existence of notes payable from all bankswith which the client does business.3. Review the bank reconciliation for new notes credited directlyto the bank account by the bank.4. Obtain confirmation from creditors who have held notes fromthe client in the past and are not currently included in thenotes payable schedule.5. Analyze interest expense to uncover a payment to a creditorwho is not included on the notes payable schedule.6. Review the minutes of the board of directors for authorizedbut unrecorded notes.22-7The primary purpose of analyzing interest expense is to uncover a payment to a creditor who is not included on the notes payable schedule. The primary considerations the auditor should keep in mind when doing the analysis are:1. Is the payee for the interest payment listed in the cashdisbursements journal also included in the notes payable list?2. Has a confirmation for notes payable been received from thepayee?22-8The tests of controls and substantive tests of transactions for liability accounts in the capital acquisition and repayment cycle consists of tests of the control and substantive tests over the payment of principal and interest and the issuance of new notes or other liabilities, whereas the testsof details of balances concern the balance of the liabilities, interest payable, and interest expense. A unique aspect of the capital acquisition and repayment cycle is that auditors normally verify the transactions and balances in the account at the same time, as described in the solution to Review Question 22-3.22-9Four types of restrictions long-term creditors often put on companies in granting them a loan are:1. Financial ratio restrictions2. Payment of dividends restrictions3. Operations restrictions4. Issue of additional debt restrictionsThe auditor can find out about these restrictions by examining the loan agreement and related correspondence associated with the loan, and by confirmation. The auditor must perform calculations and observe activities to determine whether the client has observed the restrictions.22-10T he primary objectives in the audit of owners' equity accounts are to determine whether:1. The internal controls over capital stock and related dividendsare adequate.2. Owners' equity transactions are recorded properly, as definedby the following six transaction-related audit objectives:⏹Occurrence⏹Completeness⏹Accuracy⏹Posting and summarization⏹Classification⏹Timing22-10 (continued)3.Owners' equity balances in the financial statements satisfy thefollowing balance-related audit objectives:⏹Detail tie-in⏹Existence⏹Completeness⏹Accuracy⏹Classification⏹Cutoff4.Owners' equity balances are properly presented and disclosedto satisfy the following presentation and disclosure-relatedaudit objectives:⏹Occurrence and Rights and Obligations⏹Completeness⏹Accuracy and Valuation⏹Classification and Understandability22-11A lthough the corporate charter and bylaws are legal documents, their legal nature is not being judged by the auditor. They are being used only to reference transactions being tested by the auditor and provide insight into some of the key control features of the company. The auditor should consult an attorney if the information the auditor needs from the documents is not clear or if a legal interpretation is needed.22-12T he major internal controls over owners' equity are:1. Proper authorization of transactions2. Proper record keeping3. Adequate segregation of duties between maintaining owners'equity records and handling cash and stock certificates4. The use of an independent registrar and stock transfer agent22-13T he audit of owners' equity for a closely held corporation differs from that for a publicly held corporation in that the amount of time spent in verifying owners' equity in a closely held corporation is usually minimal because of the relatively few transactions for capital stock accounts that occur during the year. For publicly held corporations, the audit of owners' equity is more complex due to the existence of a larger number of shareholders and frequent changes in the individuals holding stock.The audits are not significantly different in regard to whether the transactions in the equity accounts are properly authorized and recorded and whether the amounts in the accounts are properly classified, described, and stated in accordance with generally accepted accounting principles.22-14T he duties of a stock registrar are to make sure that stock is issued by a corporation in accordance with the capital authorization of the board of directors, to sign all newly issued stock certificates, and to make sure old certificates are received and cancelled before a replacement certificate is issued when there is a change in the ownership of the stock.The duties of a transfer agent are to maintain the stockholder records, and in some cases, disburse cash dividends to shareholders.The use of the services of a stock registrar improves the effectiveness of the client's internal controls by preventing the improper issuance of stock certificates. Along similar lines, the use of the services of an independent transfer agent improves the control over the stock records by putting them in the hands of an independent organization.22-15T he number of shares outstanding, the correct valuation of capital stock transactions, and par value can all be confirmed with a transfer agent. The balance can then be easily recalculated from this information.22-16S ince it is important to verify that properly authorized dividends have been paid to owners of stock as of the dividend record date, a comparison of a random sample of cancelled dividend checks to a dividend list prepared by management would be inadequate. Such an audit step is useless unless the dividend list has first been verified to include all stockholders of record at the dividend record date. A better test is to determine the total number of shares outstanding at the dividend date from the stock registrar and recompute the total dividends that should have been paid for comparison with the total amount actually paid.A random sample of cancelled checks should then be compared to the independent registrar's records to verify that the payments were actually made to valid shareholders.22-17I f a transfer agent disburses dividends for a client, the total dividends declared can be verified by tracing the amount to a cash disbursement entry to the agent and also confirming the amount. Thereshould ordinarily be no need to test individual dividend disbursement transactions if a stock transfer agent is used.22-18T he major emphasis in auditing the retained earnings account should be on the recorded changes that have taken place during the year, such as net earnings for the year, dividends declared, prior period adjustments, extraordinary items charged or credited directly to retained earnings, or setting up or elimination of appropriations. Except for dividends declared, the other items should be verified during other parts of the engagement. This is especially true of the net earnings for the year. Therefore, the audit of retained earnings primarily consists of an analysis of the changes in retained earnings and the verification of the authorization and accuracy of the underlying transactions.22-19F or auditing owners' equity and calculating earnings per share, it is crucial to verify that the number of shares used in each is accurate. Earnings are verified as an integral part of the entire audit and should require no additional verification as a part of owners' equity. The most important auditing considerations in verifying the earnings per share figure are the accounting principles prescribed by APB 15 and the descriptions of the various classes of stock in the corporate charter and minutes of the board of directors.Multiple Choice Questions From CPA Examinations22-20 a. (2) b. (2) c. (2)22-21 a. (4) b. (3) c. (1)Discussion Questions and Problems22-2222-23a.b. The auditor should be alert for the following provisions in thebond indenture agreement:1. Restrictions on payment of dividends2. Convertibility provisions3. Provisions for repayment4. Restrictions on additional borrowing5. Required maintenance of specified financial ratiosc. The auditor can determine whether the above provisions havebeen met by the following procedures:22-23 a. (continued)1. Audit of payments of dividends2. Determine if the appropriate stock authorizations areadequate3. Determine if sinking fund is adequate4. Search for other liabilities5. Calculate ratios and compare to agreementd. The auditor should verify the unamortized bond discount orpremium on a bond that was in force at the beginning of theyear by recalculation. This is done by dividing the premium ordiscount by the number of total months the bonds will beoutstanding and multiplying by the number of monthsremaining. For bonds issued in the current year, the bondpremium or discount must first be verified. The monthlypremium or discount is then calculated and multiplied by thenumber of months still outstanding.e. The following information should be requested from thebondholder in the confirmation of bonds payable:1. Amount of bond2. Maturity date3. Interest rate4. Payment dates5. Payment amounts6. Assets pledged as security7. Restrictions on client activities22-24a. The auditing necessary for notes payable and related interest accounts in these circumstances would be minimal. Asidefrom checking interest calculations and postings to the properaccounts as a matter of audit routine, the only major auditprocedure would be to confirm the amount and provisions ofb. If Fox was unprofitable, had a need for additional financing,and had deficient internal controls, it would be necessary tosearch for unrecorded notes. This could be done by obtainingstandard bank confirmations with specific reference to theexistence of notes payable, reviewing the bank statementsand reconciliations for new notes credited directly to the bankaccount by the bank, and analyzing interest expense touncover a payment to a creditor who is not included on thenotes payable schedule.22-25 a. The emphasis in the verification of notes payable in this situation should be in determining whether all existing notesare included in the client's records. The four audit procedureslisted do not satisfy this emphasis.b.22-25 (continued)c. Procedure 2 is not necessary in light of procedure 3. Theyboth perform the same function and the confirmation is froman independent source. The sample sizes for the proceduresare probably appropriate, considering the deficiencies inrecord keeping procedures.d. In addition to the procedures mentioned, the following onesare essential because there must be a search for unrecordednotes:1. Analyze interest expense and send a confirmation fornotes payable to all payees not receiving a confirmationfor notes.2. Confirm the balance in notes payable to payeesincluded in last year's notes payable list but notconfirmed in the current year.3. Examine notes paid after year-end to determinewhether they were liabilities at the balance sheet date.4. Obtain a standard bank confirmation that includes aspecific reference to notes payable from all banks withwhich the client does business.5. Review the minutes of the board of directors.22-26I n each case, any actual failure to comply would have to be reported in a footnote to the statements in view of the possible serious consequences of advancing the maturity date of the loan. The individual audit steps that should be taken are as follows:a. Calculate the working capital ratio at the beginning of andthrough the previous fiscal year. If it is under 2 to 1, determinecompensation of officers for compliance with the limitation.b. Examine the client's copies of insurance policies or certificatesof insurance for compliance with the covenant, preparing aschedule of book value, appraised or estimated value, andcoverage for the report. Confirm policies held with trustee.* *c. Examine vouchers supporting tax payments on all propertycovered by the indenture. By reference to the local tax lawsand the vouchers, determine that all taxes have been paidbefore the penalty-free period expired. If the vouchers in anycase are inadequate, confirm with the trustee who holds thetax receipts.d. Vouch the payments to the sinking fund. Confirm bondpurchases and sinking fund balance with trustee. Observeevidence of destruction of bonds for bonds cancelled. Reportthe fund as an asset, preferably giving the composition as tocash and bonds held alive, if any.22-27a. It is desirable to prepare an audit schedule for the permanent file for the mortgage so that the appropriate informationconcerning the mortgage will be conveniently available forfuture years' audits. This information should include all theprovisions of the mortgage as well as the purchase price, dateof purchase, and a list of items pledged as collateral. It mayalso contain an amortization schedule of principal and interest(especially if the auditor has access to a computer program forpreparation of such a schedule)b. The audit of mortgage payable, interest expense, and interestpayable should all be done together since these accounts arerelated and the results of testing each account have a bearingon the other accounts. The likelihood of misstatement in theclient's records is determined faster and more effectively bydoing them together.c. The audit procedures that should ordinarily be performed toverify the issue of the mortgage, the balance in the mortgageand interest payable, and the balance in the interest expenseaccounts are:1. Determine if the mortgage was properly authorized.* *2. Obtain the mortgage agreement and schedule thepertinent provisions in the permanent file, including theface amount, payments, interest rate, restrictions, andcollateral.3. Confirm the mortgage amount, terms, and collateralwith the lending institution.4. Recompute interest payable at the balance sheet dateand reconcile interest expense to the decrease inprincipal and the payments made.5. Test interest expense for reasonableness.d. Generally accepted accounting principles require disclosuresrelated to long-term debt. The terms of the debt agreementare to be disclosed, including interest rates, maturity dates,five-year payment information, assets pledged as collateral,among other items. Significant restrictions on the activities ofthe company, such as maintaining cash or othercompensating balances or restricting the amount of dividendsthat can be paid, should be disclosed. Thus, auditors obtaincopies of long-term debt agreements to determine that theclient’s disclosures are complete and accurate.22-2822-2922-30 T he proposal for the limitation of procedure is not justified by the stated facts. Although the transfer agent and the registrar know the number of shares issued, they do not necessarily know the number ofshares outstanding. Furthermore, the audit of capital stock includes more than determining the number of shares outstanding. For example, the auditor must determine what authorizations exist for the issuance of shares, what assets were received in payment of shares, how the transactions were recorded, and what subscription contracts have been entered into. Confirmation from the registrar could not help in determining these things.In addition to confirmation from the registrar, the audit of capital stock might include the following procedures, the purposes of which are briefly indicated:1. Examine the corporation charter―to determine the number ofshares authorized and the special provisions for each class ofstock if more than one class is authorized.* * 22-30 (continued)2. Examine minutes of stockholders' and directors' meetings―todetermine authorization for appointments of the registrar andthe transfer agent; to determine authorization for the issuanceor reacquisition of shares.3. Examine provisions regarding capital stock in the corporationlaw of the state of incorporation—to determine any specialprovisions, such as those for the issuance of no par stock.4. Analyze the capital stock accounts to obtain an orderly pictureof stock transactions for use as a guide to other auditingprocedures and as a permanent record.5. Trace the consideration received for capital stock into therecords—to determine what consideration has been receivedand how it has been recorded.6. Examine and schedule treasury stock and review entries fortreasury stock—to determine the existence of treasury stockas authorized and to determine that a proper record has beenmade.7. Review registrar's invoices and cash disbursements—todetermine that original issue taxes have been paid.8. Compare dividends with stock outstanding at dividend dates—to determine that dividends have been properly paid andalso to substantiate the stock outstanding.9. Review subscription and option contracts, etc.—to determinethe facts in regard to subscriptions and options and todetermine that these facts have been properly recorded andthat they are adequately disclosed.22-31a. The audit program for the audit of Pate Corporation's capital stock account would include the following procedures:* *1. Examine the articles of incorporation, the bylaws, andthe minutes of the board of directors from the inceptionof the corporation to determine the provisions ordecisions regarding the capital stock, such as classes ofstock, par value or stated value, authorized number ofshares, authorization for the sale of new issues oradditional sales of unissued stock, declarations of stocksplits and dividends in the form of cash or stock, andgranting of stock options or stock rights. Determinethat the accounting records are in accordance withthese provisions or decisions and that appropriatedisclosure is made by footnote if necessary. Extractpertinent data for the auditor's permanent file.2. Examine the stock certificate stub book and determinewhether the total of the open stubs agrees with theCapital Stock account in the general ledger. Examinecancelled stock certificates, which are generallyattached to the corresponding stub.22-31 (continued)Information on the stubs regarding the number ofshares, date, etc. for both outstanding and cancelledstock certificates should be compared with the CapitalStock account. All certificate numbers should beaccounted for and, if the CPA deems it necessary,confirmation of the number of certificates printedshould be obtained from theprinter. A test check should be made to determine thatthe proper amounts of original issue and capital stocktransfer taxes have been affixed to the stubs and thecancelled certificates. The stockholders shown in thestock certificate stub book should be compared with the stockholders' master file if one is maintained.3. Analyze the Capital Stock account from thecorporation's inception and verify all entries. Trace all transactions involving the transfer of cash either to the cash receipts or the cash disbursements records. If property other than cash was received in exchange for capital stock, trace the recording of the property to the proper asset account and consider the reasonableness of the valuation placed on the property. Transactions showing the sale of stock at a discount or premium should be traced to the Capital Contributed in Excess of Par Value account. If capital stock has been sold at a discount, consideration should be given to the possibleviolation of state laws and the client's attention shouldbe directed to the matter. Should the analysis of the Capital Stock account disclose that the corporation has engaged in treasury stock transactions, determine that the increase or decrease in net assets resulting from these transactions has not been placed in the Retained Earnings account.The audit procedures to be applied to the audit of the Capital Contributed in Excess of Par Value account are usually applied at the same time that the Capital Stock account is being audited because the two accounts are interrelated. The accounts should be analyzed and the entries verified when the related entries in the Capital Stock account are verified. If an entry is not related to Capital Stock account entries, as in the case of a write-off of a deficit as the result of a quasi reorganization, authorization for the entry and the supporting material should be examined.22-31 (continued)4. The following audit procedures would be applied to theRetained Earnings account:a) Analyze the account from its inception. Considerthe validity of the amounts representing incomeor loss that were closed from the Profit and Lossaccount. Amounts representing appraisalincrements or writing up of assets should beconsidered for reasonableness, and the increaseshould be reported separately from retainedearnings in the stockholders' equity section of thebalance sheet.b) Any extraordinary gains or losses carried directlyto the Retained Earnings account should beinvestigated and their treatment reviewed inrelation to generally accepted accountingprinciples.c) Entries recording the appropriation of retainedearnings or the return of such appropriationsshould be reviewed for reasonableness, andauthorization for the entries should be traced tothe proper authority. Similarly, actions of theboard of directors that affected retained earningsshould be traced to the account analysis.d) Conditions such as loan covenants or contingentliabilities that were uncovered during the auditthat might require or make desirable the placingof restrictions on retained earnings should bereviewed for proper disclosure in the financialstatements.* * e) Entries recording cash or stock dividends shouldbe traced to the minutes of the board of directorsfor authorization and traced to the Cash accountor the Capital Stock account. A separatecomputation should be made by the CPA of thetotal amount of dividends paid based upon his orher schedules of outstanding stock as an overalltest of the existence of the distributions. If stockdividends have been distributed, the amountremoved from retained earnings should bereviewed for compliance with generally acceptedaccounting principles.22-31 (continued)b. In conducting his or her audit, the CPA verifies retained earnings ashe or she does other items on the balance sheet for severalreasons. A principal reason is that the verification is anassurance or double check that no important item wasoverlooked in the audit of the accounts that were the contraor balancing part of the entry recorded in retained earnings.An example of an important item that may be overlookedwould be a balance sheet account that was closed during theyear under audit and the account removed from the generalledger current file. Another reason is that, though the entry inthe contra account may have been examined, the auditor mayhave overlooked that the balancing part of the entry was toretained earnings, a treatment that may have been contrary togenerally accepted accounting principles; his or her audit ofretained earnings would bring this noncompliance to his orher attention.Still another reason for verifying the retained earnings account is to determine whether any portion of the balance inthe account may be subject to restriction by state law or otherauthority. Since the account is the basis for the payment ofdividends, it is important to determine that the balance iscomposed of income realized from transactions free from anyrestrictions.。
Completeness
Writing assignment
The following sentence is a given topic sentence. Please develop it into a complete paragraph . Pay attention to the writing technique of unity and completeness we have discussed.
Although advertisement can be a service to people, it also h criteria of completeness a complete framework. Namely, in a paragraph, there is topic sentence, supporting sentences and a concluding sentence. it does not mean a lot of words, rather it means that you have had an adequate discussion on the topic. The readers feel that they are convinced or impressed after reading your paragraph even if they may have different ideas.
What does completeness mean?
concept :Completeness in a paragraph means that the topic is adequately developed methods: the topic can be developed by details, explanation, evidence, examples, quotation, or figures to expand the topic into a whole one, but the degree of development depends on the purpose and the content of the paragraph.
工艺工程师文件编辑范文
工艺工程师文件编辑范文英文回答：Process Engineer Documentation Template.The Process Engineer Documentation Template is a comprehensive guide for process engineers to document their work in a consistent and organized manner. It provides a standardized framework for capturing and communicating process engineering information, ensuring accuracy, completeness, and ease of retrieval.The template includes sections for:Process Overview: A high-level description of the process, including its purpose, scope, and key components.Process Flow Diagram: A visual representation of the process flow, showing the sequence of operations and their interconnections.Process Equipment List: A list of all equipment usedin the process, including their specifications, operating parameters, and maintenance requirements.Process Variables: A list of all critical process variables, including their target values, acceptable ranges, and monitoring methods.Process Control Strategy: A description of the control strategies used to maintain process variables within acceptable limits.Process Safety Analysis: A review of potential process hazards and the measures taken to mitigate risks.Process Improvement Recommendations: Suggestions for optimizing the process, improving efficiency, and reducing costs.References: A list of sources consulted for the documentation.The Process Engineer Documentation Template is an essential tool for process engineers to ensure that their work is documented in a professional and thorough manner. It promotes collaboration, knowledge sharing, and continuous improvement within the engineering team.中文回答：工艺工程师文件编辑范文。
ANSI_C12.18-2006_Ⅱ型光口协议规范
ANSI C12.18-2006 American National Standard Protocol Specification for ANSIType 2 Optical PortANSI C12.18-2006Revision ofANSI C12.18-1996American National Standard Protocol Specification for ANSI Type 2 Optical PortSecretariat:National Electrical Manufacturers AssociationApproved May 2, 2006American National Standards Institute, Inc.ANSI C12.18-2006NOTICE AND DISCLAIMERThe information in this publication was considered technically sound by the consensus of persons engaged in the development and approval of the document at the time it was developed. Consensus does not necessarily mean that there is unanimous agreement among every person participating in the development of this document.NEMA standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards development process. This process brings together volunteers and/or seeks out the views of persons who have an interest in the topic covered by this publication. While NEMA administers the process and establishes rules to promote fairness in the development of consensus, it does not write the document and it does not independently test, evaluate, or verify the accuracy or completeness of any information or the soundness of any judgments contained in its standards and guideline publications.NEMA disclaims liability for any personal injury, property, or other damages of any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, express or implied, as to the accuracy or completeness of any information published herein, and disclaims and makes no warranty that the information in this document will fulfill any of your particular purposes or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or seller’s products or services by virtue of this standard or guide.In publishing and making this document available, NEMA is not undertaking to render professional or other services for or on behalf of any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise of reasonable care in any given circumstances. Information and other standards on the topic covered by this publication may be available from other sources, which the user may wish to consult for additional views or information not covered by this publication.NEMA has no power, nor does it undertake to police or enforce compliance with the contents of this document. NEMA does not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other statement of compliance with any health or safety–related information in this document shall not be attributable to NEMA and is solely the responsibility of the certifier or maker of the statement.ANSI C12.18-2006iAMERICANNATIONALSTANDARD Approval of an American National Standard requires verification by ANSI that the requirements for due process, consensus, and other criteria for approval have been met by the standards developer.Consensus is established when, in the judgment of the ANSI Board ofStandards Review, substantial agreement has been reached by directlyand materially affected interests. Substantial agreement means muchmore than a simple majority, but not necessarily unanimity. Consensusrequires that all views and objections be considered, and that aconcerted effort be made toward their resolution.The use of American National Standards is completely voluntary; theirexistence does not in any respect preclude anyone, whether he hasapproved the standards or not, from manufacturing, marketing,purchasing, or using products, processes, or procedures notconforming to the standards.The American National Standards Institute does not develop standardsand will in no circumstances give an interpretation of any AmericanNational Standard. Moreover, no person shall have the right orauthority to issue an interpretation of an American National Standard inthe name of the American National Standards Institute. Requests forinterpretations should be addressed to the secretariat or sponsorwhose name appears on the title page of this standard.Caution Notice: This American National Standard may be revised orwithdrawn at any time. The procedures of the American NationalStandards Institute require that action be taken periodically to reaffirm,revise, or withdraw this standard. Purchasers of American NationalStandards may receive current information on all standards by calling orwriting the American National Standards Institute.Published byNational Electrical Manufacturers Association1300 North 17th Street, Rosslyn, VA 22209© Copyright 2006 by National Electrical Manufacturers AssociationAll rights reserved including translation into other languages, reserved under the Universal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions.No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission of the publisher.Printed in the United States of AmericaANSI C12.18-2006This page intentionally left blank. iiANSI C12.18-2006ContentsPage 1Scope (1)2References (1)3Definitions and Syntax (1)3.1Definitions (1)3.1.1C12.18 Client (1)3.1.2C12.18 Device (1)3.1.3Point-to-point Communications (1)3.1.4Table (2)3.2Document Syntax (2)4Protocol Details (2)4.1Order of Transmission (3)4.2Layer 7—Application Layer (3)4.2.1Data Structure (3)4.2.2Protocol Specifications for Electric Metering (3)4.2.2.1Request Codes (4)4.2.2.2Response Codes (4)4.2.2.3Identification Service (6)4.2.2.4Read Service (9)4.2.2.5Write Service (11)4.2.2.6Logon Service (12)4.2.2.7Security Service (13)4.2.2.8Logoff Service (13)4.2.2.9Negotiate Service (14)4.2.2.10Wait Service (15)4.2.2.11Terminate Service (15)4.2.2.12Partial Table Access Using the Index/element-count Method (16)4.2.2.13Index Count Access Method Examples (17)4.2.2.14Partial Table Access Using the Offset/octet-count Method (18)4.3Layer 6—Presentation Layer (19)4.4Layer 5—Session Layer (19)4.5Layer 4—Transport Layer (19)4.6Layer 3—Network Layer (19)4.7Layer 2—Data Link Layer (19)4.7.1Basic Data (19)4.7.1.1Default Settings (20)4.7.2Packet (20)4.7.3Duplicate packets (21)4.7.4CRC selection (22)4.7.5Acknowledgment (22)4.7.6Retransmission (22)4.7.7Time-out (22)4.7.7.1Channel Traffic Time-out (22)4.7.7.2Inter-character Time-out (22)4.7.7.3Response Time-out (23)4.7.8Delays (23)4.7.8.1Turn-around Delay (23)4.8Layer-1—Physical Layer (23)4.8.1Physical (23)4.8.2Basic Data (24)4.8.3Light Levels (24)4.8.3.1Optical Characteristics (24)4.8.3.2Transmitter Characteristics (24)iiiANSI C12.18-2006iv 4.8.3.3Receiver Characteristics (25)4.8.3.4Environmental Lighting Condition (26)5Compliance (26)Annex A - Communication Example (Layer 7 and Layer 2) (27)Annex B - Packet Transmission Example (29)Annex C - Service Sequence State Control (31)Annex D – Compatibility (33)D.1Backward compatibility with previous versions of the Standard (33)D.2Forward compatibility with next versions of the Standard (33)Annex E - Historical Background (35)E.1Foreword of C12.18-1996 and C12.18-1996 (R2002) (35)ANSI C12.18-2006vForeword (This Foreword is not part of American National Standard C12.18-2006.)This American National Standard provides an open-platform communications protocol for two-way communication with a metering device through an ANSI Type 2 Optical Port. The protocol is written to conform to the OSI seven-layer stack.Long-time readers of ANSI C12.18 will discover many editing changes to this version of the Standard. The Working Group chose to improve the clarity of the text as an aid to the reader while retaining the Normative elements in the manner of previous publications.The 2006 revision of this Standard was considered in the context of the so-called “protocol suite” of ANSI standards: C12.18, C12.19, C12.21 and C12.22 (draft). Changes made were included only after assuring that existing devices implementing C12.18 would continue to remain compatible with the 2005 revision.This revision has corrected an error in the original standard: the impossibility of using index-count for table access. Other concepts addressed include compliance, backward and forward compatibility, the use of reserved fields, the Identification Service, packet size and the toggle bit. Finally, some alignment with the draft C12.22 standard was performed to meet the goal of producing a coherent suite of protocol standards.Suggestions for improvement to this Standard are welcome. They should be sent to:National Electrical Manufacturers AssociationVice President of Engineering1300 North 17th StreetSuite 1752Rosslyn, VA 22209This Standard was processed and approved for submittal to ANSI by Accredited Standards Committee for Electricity Metering C12. At the time the committee approved this Standard, the C12 Committee had the following members:Tom Nelson, ChairmanPaul Orr, SecretaryMichael AndersonEd BerosetRon BreschiniCurt CrittendenDavid EllisCruz GomezBob HughesLawrence KotewaFrancis MartaJohn McEvoyHerman MillicanJames MiningAvygdor MoiseTim MorganRoy MoxleyD. Young NguyenLauren PananenAaron SnyderRichard TuckerScott WeikelANSI C12.18-2006Working Group 4 of Subcommittee 17 that developed the Standard consisted of: Aaron Snyder, ChairmanPeter Martin, Vice ChairmanNorbert Balko, EditorMichael AndersonEd BerosetMartin BurnsJanice JenningsLawrence KotewaRobert McMichaelAvygdor MoiseVuong NguyenTerry PennBin QiuRichard TuckerMichel VeilletteVirginia ZinkowskiviAMERICAN NATIONAL STANDARD ANSI C12.18-2006 Protocol Specification for ANSI Type 2 Optical Port1 ScopeThis Standard details the criteria required for communications between a C12.18 Device and a C12.18 Client via an optical port. The C12.18 Client may be a handheld reader, a portable computer, a master station system or some other electronic communications device.This Standard provides details for a complete implementation of an OSI 7-layer model.The protocol specified in this document was designed to transport data in Table format. The Table definitions are in ANSI C12.19 Utility Industry End Device Data Tables.2 ReferencesANSI C12.19, Utility Industry End Device Data TablesANSI C12.21, Protocol Specification for Telephone Modem CommunicationISO/IEC 646 (1991), Information Technology - ISO 7-Bit Coded Character Set For Information InterchangeISO/IEC 7498-1 (1994), Information Technology - Open Systems Interconnection - Basic Reference Model: The Basic ModelISO/IEC 8825-1 (2002), Information Technology - ASN.1 Encoding Rules: Specification Of Basic Encoding Rules (BER), Canonical Encoding Rules (CER) And Distinguished Encoding Rules (DER)ISO/IEC 13239 (2002), Information Technology - Telecommunications And Information Exchange Between Systems - High-Level Data Link Control (HDLC) Procedures3 Definitions and Syntax3.1 DefinitionsFor the purposes of this Standard, the following definitions are made.Client3.1.1 C12.18An electronic communication apparatus that attaches to the ANSI Type 2 Optical Port of a C12.18 Device and implements communication according to the protocol specification of this Standard.Device3.1.2 C12.18An electronic communication apparatus that implements an ANSI Type 2 Optical Port for communication according to the protocol specification of this Standard.Communications3.1.3 Point-to-pointPoint-to-point communications is defined as communication between two devices through a single optical interface.1。
Completeness Results for Fibred Parchments Beyond the Propositional Base
This work was partially supported by FCT and FEDER, namely, via the Project FibLog POCTI/MAT/372 39/2001 of CLC.
free in a formula. The idea of making these side conditions explicit is not new [21], but the technique we shall use is improved along [7, 22]. This fine control of instantiations also has an impact on fibring, again characterizable by colimits. These aspects settled, we can study soundness and completeness transfer results in a broader context. As before [5], soundness preservation is immediate, by definition of fibring. For completeness, we capitalize on the notion of fullness [25] for guaranteeing that the logics at hand have a sufficient amount of models. Under reasonable assumptions on the logics being fibred, their syntactic constructors and the properties of their proof-calculi, we also generalize the completeness preservation results of [6]. We illustrate fibring by providing a detailed analysis of modal first-order logic as a fibring of propositional modal logic and first-order logic, considering various choices for its semantics, and clarifying the importance of provisos and the applicability of the completeness results. In Section 2 we set up logic-parchments by recalling the details of c-parchments and introducing an improved version of proof-calculus. Section 3 is dedicated to fibring. After an overview of fibred semantics, we proceed to the categorial characterization of fibred logics, by understanding fibred deduction in the presence of provisos. A general soundness preservation result is also established, and the fundamental notion of fullness is introduced. In Section 4, we study completeness preservation under meaningful fullness requirements and reasonable assumptions on the syntactic constructors and the proof-calculi of the logics being fibred. We conclude by discussing the results obtained, their limitations and future work.
完整性评估
Initial Completeness Assessments for Type II API DMFs Under GDUFADRAFT GUIDANCEThis guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.For questions regarding this draft document contact Division of Drug Information at 1-866-405-5367.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)October 2012Generic DrugsInitial Completeness Assessments for Type II API DMFs Under GDUFAAdditional copies are available from:Office of Communications, Division of Drug InformationCenter for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Bldg. 51, rm. 2201Silver Spring, MD 20993-0002Tel: 301-796-3400; Fax: 301-847-8714; E-mail: druginfo@/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)October 2012Generic DrugsTABLE OF CONTENTSI.INTRODUCTION (1)II.BACKGROUND (2)III.INITIAL COMPLETENESS ASSESSMENT (2)rmation Confirmed During the Initial Completeness Assessment (3)B.Check of Initial Completeness Assessment Elements (4)IV.INITIAL COMPLETENESS ASSESSMENT OUTCOMES (4)V.API INFORMATION INCLUDED IN A GENERIC DRUG SUBMISSION (5)VI.SUMMARY (5)DEFINITIONS (6)APPENDIX 1: (7)Guidance for Industry11Initial Completeness Assessments for Type II API DMFs2Under GDUFA345678This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current 9thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 10bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of 11the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA 12staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call 13the appropriate number listed on the title page of this guidance.1415161718I. INTRODUCTION1920This draft guidance is intended for holders of Type II active pharmaceutical ingredient (API)21drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA) or an amendment or prior approval supplement (PAS) to an ANDA (generic drug2223submissions). The guidance explains that, beginning October 1, 2012, under the Generic Drug User Fee Amendments of 2012, commonly referred to as GDUFA.2242526•DMF holders are required to pay a DMF fee when first authorizing the reference of their 27DMF in a generic application, and28•Type II API DMFs must undergo an FDA initial completeness assessment.2930The guidance makes recommendations about the information that should be included in the DMF 31to facilitate an initial completeness assessment (CA). The guidance does not apply to new drug applications (NDAs), biologics license applications (BLAs), or other submissions that are not3233generic drug submissions.33435FDA’s guidance documents, including this guidance, do not establish legally enforceable36responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are3738cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.39401 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) and the Center forBiologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA or Agency).2 Public Law 112-144, Title III.3 See section 744A(7) of Federal Food, Drug and Cosmetic Act (FD&C Act).II. BACKGROUND414243Under GDUFA, beginning October 1, 2012, the holder of a Type II API DMF must pay a one 44time DMF fee when it first authorizes in a letter of authorization (LOA) the reference of its DMF 45in an ANDA, an ANDA amendment, or an ANDA PAS.4 Holders of DMFs that were evaluated 46before October 1, 2012 will also be required to pay a fee for the DMF when their DMF is first 47referenced in a new ANDA, an ANDA amendment, or an ANDA PAS on or after October 1,482012. The fee amount and fee due date will be announced in a notice in the Federal Registe r. 49Only Type II API DMFs for use in generic drug submissions incur this one-time fee.5051In addition, GDUFA requires Type II API DMFs to undergo an initial CA5 to ensure that theDMF is complete. Although the requirement for an initial CA for Type II API DMFs is new, the5253elements of the initial CA have been used previously by FDA to evaluate DMFs. DMFs that54have paid the fee and been found to be complete in accordance with the criteria for an initial CA set out in the attached checklist will be identified on FDA’s public Web site as available for5556reference in support of a generic drug submission. When submitting a DMF, the DMF holder 57should also submit Form FDA 3794, the Generic Drug User Fee Cover Sheet, which requests the 58minimum information necessary to determine if a DMF holder has satisfied all relevant user fee 59obligations.6061Note: DMF holders are encouraged, but not required, to submit their DMFs using the Electronic 62Common Technical Document (eCTD) format. More information is available on the eCTD63format on FDA’s Web site and in the ICH guidance M4Q.6646566III. INITIAL COMPLETENESS ASSESSMENT6768FDA will perform an initial CA once a DMF holder files a Type II API DMF7 with the generic 69drug user fee cover sheet (Form FDA 3794) and the fee payment has been verified. Note: the70initial CA does not replace the full scientific review, which is performed to determine the71adequacy or inadequacy of the information contained in the DMF to support an ANDA review 72decision.7374In brief, FDA will undertake an initial CA to determine the following:75•Is the DMF active?7677•Has the fee been paid?4Section 744B(a)(2) of the FD&C Act. For discussion of letters of authorization, see 21 CFR 314.420(b) and314.50(g)(1).5 Section 744B(a)(2)(D)(ii) of the FD&C Act.6 See information about electronic submissions at:/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/uc m153574.htm and ICH M4Q:/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf.7 See Drug Master Files at:/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/d efault.htm.•Has the DMF been previously reviewed?7879•Does the DMF pertain to a single drug substance?80•Does the DMF contain certain administrative information?•Does the DMF contain all the information necessary to enable a scientific review?88182•Is the DMF written in the English language?98384FDA will conduct the initial CA by completing a series of questions listed in the GDUFA Initial 85Completeness Assessment Checklist for Type II API DMFs, which is included in Appendix 1.86This guidance provides additional detail on the kinds of information FDA will confirm when87performing an initial CA on a DMF.8889rmation Confirmed During the Initial Completeness Assessment90FDA will use the initial CA Checklist (see Appendix 1) to perform the initial CA. At the top of9192the cover page of the checklist, FDA will fill in basic information about the DMF, including its 93name, number, receipt date, and whether the DMF was submitted in electronic or paper format.94The FDA will also note whether the primary DMF that is referenced by the ANDA contains any 95references to other DMFs (subject DMFs). A primary DMF can reference subject DMFs (such 96as a DMF that describes the manufacture of a material used in producing the active ingredient),10 97which provides additional information needed to completely describe the manufacture of a drug 98substance.99100Note: Before submitting its DMF, the primary DMF holder should check with the holders of any 101referenced subject DMFs to make sure that they are filed with FDA and are still consideredactive DMFs. If a referenced DMF is not yet filed or has become inactive, FDA would consider 102103the primary DMF to be incomplete.1041051. Confirm that DMF fee has been paid.106Before assigning a DMF to a reviewer for an initial CA, FDA will confirm that the DMF fee has 107108been paid. If the fee has not been paid, FDA will not assign the DMF to a reviewer for an initial 109CA. Note: ANDA applicants that reference a DMF for which a fee is due but has not been paid 110will be notified that the DMF holder has not paid the fee. If the DMF fee is not paid within 20 111days after notification, the ANDA referencing the DMF will not be received.1121132. Is the DMF active?114115If the primary DMF or any referenced subject DMFs on file at FDA are inactive, FDA will116consider the primary DMF incomplete and send the DMF holder a letter notifying them that the 117DMF is incomplete and identifying the missing elements in the DMF that must be addressed.8See Drug Master Files at:/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/d efault.htm,andICH M4Q: /fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf.9 If a DMF contains information in another language, an accurate certified English translation must also be included.10 If a subject DMF does not meet the definition of a Type II API DMF, it will not incur a DMF fee.1181193. Has the DMF been previously reviewed for chemistry, manufacturing, and controls 120(CMC) by FDA in the context of a review of a prior application?121122If FDA has reviewed the DMF for CMC after November 30, 2007, the DMF will be considered 123to have passed the initial CA without further analysis. If the DMF has not previously received 124this full review, then it will be assigned to a reviewer for an initial CA.125126B.Check of Initial Completeness Assessment Elements127128FDA also will complete the administrative part of the checklist (General Information) during the 129initial CA. The DMF will be deemed incomplete if any item in the checklist is marked “no” 130(other than item #2, which asks if the DMF needs to be updated and an answer of “yes” will 131result in an incomplete status). Then, FDA will send the DMF holder an Incomplete Letter. 132Generally, this letter will provide comments about each element that resulted in an incomplete 133designation for the initial CA. Exceptions are specified in this guidance document.134135If an item is marked “n/a,” and the element does not apply to the DMF, then element is treated 136the same as if it were marked “yes.”1371381. Subject of the DMF is a single drug substance produced by one manufacturing process 139140A DMF should be limited to one drug substance and one manufacturing process. If a DMF141includes information for more than one drug substance, or if it contains more than one142manufacturing process, the DMF will be deemed incomplete. If the DMF describes multiple 143drug substances, the DMF holder should file separate DMFs for each substance. Similarly, if 144there are multiple manufacturing processes for a drug substance, the DMF holder should file 145separate DMFs for each manufacturing process.1461472. DMF holder needs to submit a complete update148149If it has been 5 years or more since the DMF has received a complete update, or if there havebeen more than a combination of 5 amendments and annual updates to the DMF, the DMF150151holder should provide a complete and comprehensive update to it. If the DMF does not include such an update, FDA will consider the DMF incomplete.152153154FDA believes that the remainder of the initial CA checklist is self-explanatory.155156157IV. INITIAL COMPLETENESS ASSESSMENT OUTCOMES158159Following the initial CA, FDA will find the DMF either complete or incomplete. If the DMF is 160found complete, FDA will post the DMF number on a publicly available list on FDA’s Web site to indicate that the DMF is available for reference by generic drug applicants.1116116211 For the public list of DMFs available for reference, see /gdufa.If the DMF is incomplete, the initial CA findings and comments will be compiled in an163164Incomplete Letter to the DMF holder explaining why the DMF was found incomplete.165Information about the initial CA status of a DMF, other than public listing on the Web site, will not be provided to anyone except for the DMF holder.166167168169V. API INFORMATION INCLUDED IN A GENERIC DRUG SUBMISSION170171If a generic drug submission contains all the necessary API information and does not rely on 172information contained in a DMF, no initial CA will be needed. However, because GDUFA173requires collection of a one-time fee for API information included in a generic drug submission(i.e., an (a)(3)(F) fee),12 the applicant submitting the generic drug submission containing the API 174175information will be required to pay this fee.176177VI. SUMMARY178179180In summary, once the DMF fee is received, FDA will evaluate the DMF to make sure it meets 181the initial CA criteria.182183•If the DMF passes the initial CA, the DMF number will be made publicly available on 184FDA’s Web site.185•If the DMF fails the initial CA, FDA will send an Incomplete Letter describing the186missing elements to the DMF holder.187•If a generic drug submission contains all the necessary API information and does not 188reference a DMF, the applicant will be required to pay the (a)(3)(F) fee. No initial CA 189will be conducted.19012 Section 744B(a)(3)(F) of FD&C Act.191192DEFINITIONS193Active Pharmaceutical Ingredient13 (as defined by GDUFA):194195196(A) a substance, or a mixture when the substance is unstable or cannot be transported on itsown, intended—197198(i) to be used as a component of a drug; and199(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, 200mitigation, treatment, or prevention of disease, or to affect the structure or any201function of the human body; or202(B) a substance intended for final crystallization, purification, or salt formation, or any 203combination of those activities, to become a substance or mixture described in204subparagraph (A).205206Active DMF: A DMF for which FDA has made a determination that the DMF was acceptable 207for filing administratively, and is up-to-date.208209DMF Holder14: Designated owner of the DMF, which may be different from the U.S. agent 210listed as the contact.211212Generic Drug Submission15: An abbreviated new drug application (ANDA), an amendment to 213an ANDA, or a prior approval supplement (PAS) to an ANDA.214215Letter of Authorization (LOA)16: A written statement by the holder or designated US agent or 216representative permitting FDA to refer to information in the DMF in support of another person's 217generic drug submission.218219Type II Active Pharmaceutical Ingredient Drug Master Files17: Information submitted by a 220person that intends to authorize FDA to reference the information to support approval of a221generic drug submission without the submitter having to disclose the information to the generic 222drug submission applicant. In addition, the submission provides confidential detailed223information about facilities, processes, or articles used in the manufacturing, processing,224packaging, and storing of the drug substance (or drug substance intermediate and material used 225in preparation of drug product).22613 Section 744A(2) of FD&C Act.14 See 21 CFR 314.420(a).15 Section 744A(7) of FD&C Act.16 See Drug Master Files at:/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/d efault.htm.17 Section 744A(12) of FD&C Act; also see 21 CFR 314.420(a)(2).APPENDIX 1: GDUFA INITIAL COMPLETENESS ASSESSMENT CHECKLIST FOR 227TYPE II API DMFs 228229230 231 232 233 234 235236 237 238 239 240 241242243244 1. Has the GDUFA fee been paid? Enter date paid: 245 246 Yes No 247 248 2. Is the DMF active? 249 250 Yes No 251 252 If no, DMF is INCOMPLETE per policy. Issue Incomplete Letter to DMF holder. 253 254 3. Has the DMF been reviewed, after November 30, 2007, for chemistry, manufacturing and controls (CMC) by 255 FDA in the context of a review of a prior application? 256 257 Yes No 258 259 If “yes,” the DMF is COMPLETE per policy. 260 If “no,” review DMF with checklist. 261 262263 264 265 266267Checklist Review 268269270271 2722731274275276 MODULE 3: QUALITY 277 3.2 Body of Data2782791DMF holders are encouraged, but not required, to submit files in eCTD format. See information about electronic submissions at:/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/uc m153574.htm and ICH M4Q:/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf .280 281282283。
NP-completeness results for NONOGRAM via parsimonious reductions
2,3 3 1,1,1 1,1 1 2 2 2 1 1 1 1 1 1
(a)
2,3 3 1,1,1 1,1 1 2 2 2 1 1 1 1 1 1
(b)
Figure 1: An instance of NONOGRAM and its solution It is not so hard to show that NONOGRAM itself is NP-complete. Notice that even if a problem X is NP-complete, it does not always imply that ANOTHER SOLUTION PROBLEM (ASP) for X is NP-complete. In fact, for some NP-complete problem, such as Vertex Coloring, ASP is trivial. Thus, we need to nd some way to determine whether ASP for a given X is NP-complete. Here we propose one approach: First for some problem Y , show that ASP for Y is NP-complete. Then show a parsimonious reduction from Y to X that has the following additional property: (3) given a solution for an instance for Y , a solution for the corresponding instance for X is computable in polynomial time. (Recall that parsimonious reductions are reductions that preserve the number of solutions [3]. Hence if ASP for Y is NP-complete, and Y is reducible to X via such parsimonious reduction, then ASP for X is NP-complete.) In this paper, we show that ASP for NONOGRAM is NP-complete by showing (i) that ASP for 3-DIMENSIONAL MATCHING (3DM) is NP-complete, and (ii) a parsimonious reduction from 3DM to NONOGRAM with the above property (3).
ANSI 20C18.1M Part-2
ANSI C18.1M, Part 2-2011 American National Standard for Portable Primary Cells and Batterieswith Aqueous Electrolyte—Safety StandardANSI C18.1M, Part 2-2011Revision of ANSI C18.1M, Part 2-2003American National Standardfor Portable Primary Cells and Batterieswith Aqueous Electrolyte—Safety StandardSecretariat:National Electrical Manufacturers AssociationApproved December 22, 2010American National Standards InstituteANSI C18.1M, Part 2-2011NOTICE AND DISCLAIMERThe information in this publication was considered technically sound by the consensus of persons engaged in the development and approval of the document at the time it was developed. Consensus does not necessarily mean that there is unanimous agreement among every person participating in the development of this document.ANSI standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards development process. 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Consensus requires that allviews and objections be considered, and that a concerted effort be madetoward their resolution.The use of American National Standards is completely voluntary; theirexistence does not in any respect preclude anyone, whether he hasapproved the standard or not, from manufacturing, marketing, purchasing, orusing products, processes, or procedures not conforming to the standards.The American National Standards Institute does not develop standards andwill in no circumstances give an interpretation of any American NationalStandard. Moreover, no person shall have the right or authority to issue aninterpretation of an American National Standard in the name of the AmericanNational Standards Institute. Requests for interpretations should beaddressed to the secretariat or sponsor whose name appears on the titlepage of this standard.CAUTION NOTICE: This American National Standard may be revised orwithdrawn at any time. The procedures of the American National StandardsInstitute require that action be taken to reaffirm, revise, or withdraw thisstandard no later than five years from the date of approval. Purchasers ofAmerican National Standards may receive current information on allstandards by calling or writing the American National Standards Institute.Published byNational Electrical Manufacturers Association1300 North 17th Street, Rosslyn, VA 22209© Copyright 2011 by the National Electrical Manufacturers AssociationAll rights reserved including translation into other languages, reserved under the Universal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions.No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior writtenpermission of the publisher.Printed in the United States of AmericaANSI C18.1M, Part 2-2011This page intentionally left blank. iiANSI C18.1M, Part 2-2011ContentsForeword (v)1Introduction (1)2Scope (1)3Normative References (1)4Definitions (1)5Requirements for Safety (3)5.1Design (3)5.1.1General (3)5.1.2Battery Case (3)5.1.3Venting (3)5.1.4Attitude (Orientation) (3)5.1.5Multi-Cell Molded Plastic Battery Enclosure (4)5.2Intended Use Requirements (4)5.3Reasonably Foreseeable Misuse Requirements (4)5.4Design Consideration Requirements (4)5.5Quality Assurance Plan (4)6Sampling for Type Approval (5)7Testing and Compliance (Verification) (5)7.1General (5)7.1.1Test Temperature (5)7.2Pretest Dimensions, Voltage, and Insulation Resistance Test Requirements (6)7.2.1Dimensions (6)7.2.2Open Circuit Voltage (6)7.2.3Closed Circuit Voltage (6)7.2.4Insulation Resistance Test (6)7.3Intended Use Simulation Tests (7)7.3.1Test A: Partial Use (7)7.3.2Test B: Vibration (7)7.3.3Test C: Thermal Shock (8)7.3.4Test D: Mechanical Shock (9)7.4Reasonably Foreseeable Misuse Tests (10)7.4.1Test E: Incorrect Installation (10)7.4.2Test F: External Short-Circuit (11)7.4.3Test G: Free Fall (User Drop) (12)7.4.4Test H: Over-Discharge (12)7.4.5Test I: Crush (13)7.5Design Consideration Tests (14)7.5.1Test J: Thermal Abuse (14)7.5.2Test K: Mold Stress (15)8Information for Safety (18)iiiANSI C18.1M, Part 2-20119Instructions for Use (18)10Marking (19)10.1General (19)10.2Small Size Batteries (19)Annex A Guidance for Device Designers (21)Annex B Guidance for Packaging, Handling, and Transportation (28)Annex C Bibliography (30)TablesTable 1 Sampling for Type Approval (5)Table 2 Vibration Test Sequence (8)Table 3 Shock Pulse (9)Table 4A Tests Required for Single Cell Batteries (16)Table 4B Tests Required for Multi-Cell Batteries (17)Table 5 Suggested Minimum Diameters for Coil Spring Wire (27)FiguresFigure 1 Small Cell or Battery Gauge (Inner Dimensions) (3)Figure 2 Circuit Diagram for Test E: Incorrect Installation (10)Figure 3 Circuit Diagram for Test F: External Short-Circuit (11)Figure 4 Circuit Diagram for Test H: Over-Discharge (13)Figure 5 Example of Series Connection with One Battery Reversed (21)Figure 6 Positive Contact, Contact Recessed Between Ribs (23)Figure 7 Positive Contact, Recessed Aperture (23)Figure 8 Negative Contact, Contact is “U” Shaped (24)Figure 9A (25)Figure 9B (25)Figure 10A Example of a Short Circuit—A Switch is Piercing the Battery Insulating Jacket (25)Figure 10B Example of Insulation to Prevent Short Circuit—Insulating Material Positioned as Shown Prevents the Switch from Damaging the Battery Jacket (26)Figure 11 Examples Showing Distorted Springs (26)Figure 12 One Example of Protected Insertion Design (27)ivANSI C18.1M, Part 2-2011vForeword (This foreword is not part of American National Standard C18.1M, Part 2-2011.)In 1912, a committee of the American Electrochemical Society recommended standard methods to be used in testing dry cells. Their recommendations were followed five years later when the National Bureau of Standards (currently the National Institute of Standards and Testing) prepared specifications that included cell sizes, arrangement of cells within batteries, service tests, and required performance.The need for continued revision to the specification led to the authorization, by the American Engineering Standards committee, of a permanent sectional committee on dry cells. This committee, C18, representing battery users, manufacturers, and government agencies, has remained active since that time. Committee C18 prepared ANSI Standard C18.1M, Part 2, upon which this document is originally based under the sponsorship of the National Electrical Manufacturers Association (NEMA).ANSI Standard C18.1M, Part 2 was created in parallel with the International Electrotechnical Commission (IEC) project to develop a product safety standard for primary batteries with aqueous electrolyte (IEC Publication 60086-5). This revision was undertaken to update the safety tests and content in ANSI Standard C18.1M, Part 2 and to keep them current with the best possible practices.Suggestions for the improvement of this standard are welcome. They should be sent to the National Electrical Manufacturers Association, 1300 N. 17th Street, Suite 1752, Rosslyn, VA 22209, Attention: Secretary ANSI ASC C18.This standard was processed and approved for submittal to ANSI by the Accredited Standards Committee C18 on Portable Cells and Batteries. Committee approval of the standard does not necessarily imply that all committee members voted for its approval. At the time it approved this standard, the C18 committee had the following members:Michael H. Babiak, ChairpersonSteven Wicelinski, Vice-chairpersonBen Biroschak, SecretaryOrganization Represented: Name of Representative:BAE Systems Andrew J. MarkowBureau Veritas, Consumer Product Services Thomas HeckmanDuracell Steven Wicelinski S. Keel Kelly (Alternate)Eastman Kodak Company James C. DeJagerEnergizer Battery Manufacturing, Inc. Michael H. BabiakMarcus K. Boolish (Alternate)Fisher Price / Mattel Douglas G. GoldeIntertek ETL SEMKO Robert ArmstrongKids II Robert J. CoughlinPanasonic Battery Corporation of America Charles P. MonahanANSI C18.1M, Part 2-2011vi Portable Power Consultants Ramesh V. ShahSGS Jody M. LeberSpectrum Brands, Inc. John L. HadleyDenis Carpenter (Alternate)Tiburon Associates James A. GucinskiUnderwriters Laboratories Laurie B. FlorenceThe members of Subcommittee C18-5 on Safety Standards who contributed to the development of this standard are:Keel Kelly, ChairpersonRamesh Shah, Vice-chairpersonBen Biroschak, SecretaryMichael Babiak James Gucinski Marcus Boolish John HadleyRobert Coughlin Jody LeberJames DeJager Andrew MarkowLaurie Florence Charles MonahanDouglas Golde Steven WicelinskiAMERICAN NATIONAL STANDARD ANSI C18.1M, PART 2-2011For Portable Primary Cells and Batteries with Aqueous Electrolyte—Safety Standard1 IntroductionThe concept of safety is closely related to safeguarding the integrity of people and property. This standard defines performance requirements for primary batteries with aqueous electrolyte to ensure their safe operation under normal use and reasonably foreseeable misuse.Safety is a balance between freedom from risk of harm and other demands to be met by the product. There can be no absolute safety. Even at the highest level of safety, the product can only be relatively safe. In this respect, decision-making is based on risk evaluation and safety judgment.As safety will pose different problems, it is impossible to provide a set of precise provisions and recommendations that will apply in every case. This may be particularly true for button type batteries. However, this standard, when followed on a judicious “use when applicable” basis, will provide reasonably consistent standards for safety.2 ScopeThis American National Standard specifies tests and requirements for portable primary batteries with aqueous electrolyte and zinc anode (non-lithium) to ensure their safe operation under normal use and reasonably foreseeable misuse. For reference, the chemical systems standardized in ANSI C18.1M, Part 1 are:Carbon zinc (Leclanché and zinc chloride types);Alkaline manganese dioxide;Silver oxide;Zinc air;Nickel o xy-hydroxide.References3 NormativeThe following standards contain provisions which, through reference in this text, constitute provisions of this American National Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this American National Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below.ANSI C18.1M, Part 1, American National Standard for Portable Primary Cells and Batteries with Aqueous Electrolyte—General and Specifications1。
病案归档率评审标准
病案归档率评审标准Medical record archiving rate review is an essential process in healthcare institutions to ensure quality patient care and data management. 病案归档率评审是医疗机构中一个至关重要的流程，可以确保患者护理质量和数据管理。
It involves evaluating the accuracy, completeness, and timeliness of medical records being archived for future reference and retrieval. 它涉及评估医疗记录的准确性、完整性和及时性，以备将来参考和检索。
Achieving a high level of accuracy and compliance with regulatory standards is crucial in maintaining efficient workflow and promoting patient safety. 实现高水平的准确性和遵守法规标准对于保持高效的工作流程和促进患者安全至关重要。
One of the key factors in determining the success of medical record archiving rate review is the establishment of clear and concise guidelines. 确定病案归档率评审成功的关键因素之一就是制定明确简洁的指导方针。
These guidelines should outline the criteria for evaluating the completeness and accuracy of medical records, as well as the timeframe for archiving and retrieval of records. 这些指导方针应该概述评估病案完整性和准确性的标准，以及病案归档和检索的时间安排。
退休职工调取档案流程
退休职工调取档案流程英文回答：Retrieving retirement records for retired employees involves a specific process that ensures the privacy and security of the individual's personal information. The procedure typically begins with the retiree submitting a formal request to the relevant department or agency responsible for maintaining the retirement records. This request can be made either in person, via mail, or through an online platform, depending on the available options.Once the request is received, the department or agency will verify the retiree's identity and eligibility to access the records. This may involve providingidentification documents, such as a government-issued ID or a retirement identification card. The retiree may also need to provide additional information, such as their social security number or employee identification number, toassist in locating the specific records.After the retiree's identity and eligibility are confirmed, the department or agency will initiate the retrieval process. This typically involves locating the retiree's file within their database or physical archives. The time required for retrieval can vary depending on the efficiency of the department or agency and the volume of requests they receive. In some cases, retirees may need to wait for a certain period before their records can be retrieved.Once the retirement records are located, they are reviewed for completeness and accuracy. This ensures that all relevant information, such as employment history, salary details, and retirement benefits, is included in the records. If any discrepancies or missing information are identified, the retiree may be contacted to provide additional documentation or clarification.Upon completion of the review, the retirement records are prepared for release to the retiree. This may involve making copies of the relevant documents or creating adigital file that can be securely transmitted. The retiree may be required to pay a fee for the retrieval and copying of the records, depending on the policies of the department or agency.In conclusion, the process of retrieving retirement records for retired employees involves submitting a formal request, verifying identity and eligibility, locating and reviewing the records, and preparing them for release. Itis essential to follow the specific procedures outlined by the department or agency responsible for maintaining the records to ensure a smooth and efficient retrieval process.中文回答：退休职工调取档案的流程涉及确保个人信息的隐私和安全的具体过程。
佛山旅游景区质量等级评定标准
佛山旅游景区质量等级评定标准1.旅游景区的风景优美程度是评定标准之一。
The beauty of the tourist attractions is one of the evaluation criteria.2.景区设施设备的齐全性是评定标准之一。
The completeness of the facilities in the scenic area is one of the evaluation criteria.3.景区的服务水平是评定标准之一。
The service level of the scenic area is one of the evaluation criteria.4.景区的文物保护工作是评定标准之一。
The protection of cultural relics in the scenic area is one of the evaluation criteria.5.景区的环境卫生状况是评定标准之一。
The environmental sanitation of the scenic area is one of the evaluation criteria.6.景区的安全管理工作是评定标准之一。
The safety management of the scenic area is one of the evaluation criteria.7.景区的整体管理水平是评定标准之一。
The overall management level of the scenic area is one of the evaluation criteria.8.景区的宣传推广工作是评定标准之一。
The promotion and publicity work of the scenic area is one of the evaluation criteria.9.景区的游客满意度是评定标准之一。
出科病历归档制度及流程
出科病历归档制度及流程英文回答：Medical Record Filing System and Process.1. Collection and Preparation of Medical Records.Medical records are collected from various sources, including patient charts, laboratory results, imaging studies, and other relevant documentation.Records are reviewed for completeness and accuracy, and any missing or incomplete information is obtained.Records are organized and indexed for easy retrieval.2. Storage and Security.Medical records are stored in a secure location with controlled access.Physical and electronic security measures are implemented to protect the confidentiality and integrity of records.Records are stored for a specified period of time as required by law and regulations.3. Filing and Indexing.Records are filed in a systematic manner based on patient identifier, medical record number, or other relevant criteria.Indexing systems are used to facilitate quick and accurate retrieval of records.Cross-referencing and linking of records is maintained to ensure comprehensive patient information.4. Retrieval and Access.Authorized personnel can request medical records for specific patients.Requests are processed promptly and efficiently.Access to records is controlled to protect patient privacy and confidentiality.5. Disposal and Destruction.Medical records are disposed of or destroyed according to established guidelines and regulations.Records may be destroyed after a certain period of time or when they are no longer clinically relevant.Secure disposal methods are used to ensure thatpatient information is not compromised.中文回答：出科病历归档制度及流程。
科技型中小企业信息库入库流程
科技型中小企业信息库入库流程As a technology-based small and medium-sized enterprise (SME), the process of entering information into a database is crucial for organization and efficiency. This process involves capturing, storing, and managing data in a systematic way to enable easy access and retrieval. It plays a significant role in decision-making, strategic planning, and overall business operations. The information must be accurate, up-to-date, and well-organized to ensure the smooth functioning of the enterprise.作为一家科技型中小企业(SME)，将信息输入到数据库中的过程对于组织和效率至关重要。
这个过程涉及以系统化的方式捕获、存储和管理数据，以便轻松访问和检索。
它在决策制定、战略规划和整体业务运营中发挥着重要作用。
信息必须准确、及时、并且组织良好，以确保企业的顺畅运作。
The first step in the information database entry process is gathering relevant data from various sources. This could include market research reports, customer feedback, financial statements, and product specifications. It is essential to gather data that is pertinent to the business goals and objectives to ensure the database is usefuland valuable. Once the data is collected, it needs to be carefully reviewed and validated for accuracy and completeness before being entered into the database.信息数据库录入过程的第一步是从各种来源收集相关数据。
全国教师平台上非编教师辞职处理的操作流程
全国教师平台上非编教师辞职处理的操作流程1.登录全国教师平台，找到非编教师辞职处理入口。
Log in to the national teacher platform and find the entry for the resignation process for non-staff teachers.2.点击进入非编教师辞职处理页面，填写个人信息。
Click to enter the resignation process for non-staff teachers and fill in personal information.3.在系统中选择辞职原因，并填写详细说明。
Select the reason for resignation in the system and provide a detailed explanation.4.提交辞职申请，并等待审核。
Submit the resignation application and wait for it to be reviewed.5.若申请通过审核，系统会生成辞职协议书。
If the application is approved, the system will generatea resignation agreement.6.下载并签署辞职协议书，同时打印备份。
Download and sign the resignation agreement, and print a backup.7.将签署的辞职协议书提交给学校人事部门。
Submit the signed resignation agreement to the school's human resources department.8.等待学校人事部门审核并确认。
Wait for the school's human resources department to review and confirm.9.如有任何补充材料，及时提供并补全。
给排水工程资料管理流程
给排水工程资料管理流程1.初步整理资料，包括设计图纸、施工记录等。
Preliminary sorting of data, including design drawings, construction records, etc.2.对资料进行分类归档，确保清晰明了。
Classify and file the data to ensure clarity.3.编制资料管理计划，明确各项工作任务和责任人员。
Develop a data management plan, clarify the tasks and responsibilities of each person.4.确保施工过程中的资料记录完整性和准确性。
Ensure the completeness and accuracy of the data records during the construction process.5.建立定期备份机制，防止资料丢失。
Establish a regular backup mechanism to prevent data loss.6.对重要资料进行加密存储，确保安全性。
Encrypt important data for secure storage.7.确保施工人员严格按照资料管理流程操作。
Ensure that construction personnel strictly follow thedata management process.8.定期对已归档的资料进行检查，防止遗漏或损坏。
Regularly inspect archived data to prevent omissions or damage.9.对文件进行编号和标注，方便查找和追溯。
Number and label the files for easy retrieval and tracing.10.对资料进行数字化处理，便于管理和利用。
需求矩阵概念及实践
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While Truth Table is Bi-state, Requirement Matrix is Tri-state, ie. “T”(rue), “F”(alse) and “” (Ignored), for which the cell is left un-entered Number of cases = 2(number of business rules), thus 2 rules are completely described in 4 cases However, Invariant is a special rule with enumerated Elements that, in this example: Number of cases = (Number of Elements in Invariant + 1 ) * 2(number of business rules remaining) = (2+1)*21 = 6 Why are there only 5 shown? Homonyms are collapsed to provide better clarity
Requirementp lMatrix Concepts & Im ementation
Building Quality Applications
需求矩阵概念及实践
An End-to-end Paradigm in Building Quality Applications
Bronnie F Tse 立方体科技
© BfT
sentence连续性
Sample
The Irish countryside is very beautiful.[1] There is a popular Irish song which says that there are 100 different shades of green in the Irish landscape, and this is no exaggeration.[2]Thanks to generous rainfall, much of the countryside is covered in rich green vegetation, which is why Ireland is also known as the Emerrald Isle.[3] It also has a varied landscape with dramatic mountains, rocky coastlines and rolling hills.[4]
Completeness
Definition of Completeness Checklist for paragraph Completeness Exercises
Definition of Completeness completeness--- it explores the main idea explicitly and concretely, with plenty of details, examples, and explanations.
Homework
Tourism is a booming business in China. However, some people worry that too many tourists may bring harm to the environment, while others don't think so. What is your opinion?
团员档案管理流程
团员档案管理流程【中英文版】英文文档内容：The Management Process of T eam Member ArchivesThe management process of team member archives is a crucial aspect of ensuring the smooth operation of any organization.It involves the systematic documentation and organization of member information, enabling easy access and retrieval when needed.Here is an outline of the management process:1.Collection of member information: The first step in the process is to collect relevant information from each team member.This includes personal details such as name, contact information, date of birth, and employment history, as well as any other relevant information that may be required for the organization"s operations.2.Verification of member information: Once the information is collected, it is important to verify its accuracy and completeness.This may involve cross-referencing the information with official documents such as identification cards, resumes, or employment contracts.3.Documentation of member information: The next step is to document the collected information in a secure and organized manner.This can be done using a digital database or a physical filing system, depending on the organization"s preferences and resources.4.Access and retrieval: It is essential to ensure that the archived member information can be easily accessed and retrieved when needed.This may involve setting up a secure login system or providing authorized personnel with access to the database or filing system.5.Regular updates: Member information may change over time, such as contact details or job roles.It is important to update the archived information regularly to ensure its accuracy and relevance.6.Data protection: To protect member information from unauthorized access or misuse, it is crucial to implement appropriate security measures.This may include encryption of digital data, secure physical storage, and restricted access to the information.pliance with regulations: Organizations must ensure that their management of team member archives complies with relevant laws and regulations, such as data protection acts and employment laws.By following these steps, organizations can effectively manage their team member archives, ensuring easy access to information when needed while protecting the privacy and security of their members.中文文档内容：团员档案管理流程团员档案管理流程是确保任何组织运转顺畅的关键方面。
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Application P a p e r s
Case-Based Reasoning for Autonomous Service Failure Diagnosis and Remediation in Software Systems Stefania Montani, Cosimo Anglano Tracking Concept Drift at Feature Selection Stage in SparaHunting: An Anti-spam Instance-Based Reasoning System Jose Ramön Mindez Reboredo, Florentino Fernandez-Riverola, Eva Lorenzo Iglesias, Fernando Diaz Gomez, Juan Manuel Corchado [ Case-Based Support for Collaborative Business Ralph Bergmann, Andrea Freßmann, Kerstin Ramer Maximini, Thomas Sauer ...
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A CBR-Based Approach for Supporting Consulting Agencies m Successfully Accompanying a Customer's Introduction of Knowledge Management Mark Hefke, Andreas Abecker .. The PwC Connection Machine: An Adaptive Expertise Provider Mehmet H. Göker, Cynthia Thompson, Simo Arajärvi, Kevin Hua Author Index
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Multi-agent Case-Based Reasoning for Cooperative Reinforcement Learners Thomas Gabel, Martin Riedmüler Retrieving and Reusing Game Plays for Robot Soccer Raquel Ros, Manuela Veloso, Ramon Lopez de Mäntaras, Carles Sierra, Josep Lluis Areas Self-organising Hierarchical Retrieval in a Case-Agent System Ian Watson, Jens Trotzky COBRAS: Cooperative CBR System for Bibliographical Reference Recommendation Hager Karoui, Rushed Kanawati, Laure Petrucci A Knowledge-Light Approach to R.egression Using Case-Based Reasoning Neil McDonnell, Pddraig Cunninyharn Case-Base Maintenance for CCBR-Based Process Evolution Barbara Weber, Manfred Reichert, Werner Wild
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Evaluatiiig CBR Systems Using Different Data Sources: A Case Study Mingyang Gu, Agnar Aamodt Decision Diagrams: Fast and Flexible Support for Case Retrieval and Recommendation Ross Nicholson. Derek Bridge, Nie Wilson Case-Based Reasoning for Knowledge-Intensive Template Selection During Text Generation Raquel Hemds, Pablo Gervds Rough Set Feature Selection Algorithms for' Textual Case-Based Classification Kalyan Moy Gupta, David W. Aha, Philip G. Moore Experience Management with Case-Based Assistant Systems Mirjam Minor The Needs of the Many: A Case-Based Group Recommcnder System Kevin McCarthy, Lorraine McGinty, Barry Smyth, Maria Solamö Contextualised Ambient Intelligence Through Case-Based Reasoning Anders Kofod-Petersen, Agnar Aamodt Improving Annotation in the Semantic Web and Case Authoring in Textual CBR Juan A. Recio-Garcia, Marco Antonio Gömez-Martin, Belen Diaz-Agudo, Pedro A. Gonzalez-Calero Unsupervised Case Memory Organization: Analysing Computational Time and Soft Computing Capabilities Albert Fornells Herrera, Elisabet Golobardes i Ribe, David Verriet Bellet, Guiomar Corral Torruella Further Experiments in Case-Based Collaborative Web Search Jül Freyne, Barry Smyth Finding Similar Deductive Consequences - A New Search-Based Framework for Unified Reasoning from Cases and General Knowledge Ralph Bergmann, Babak Mougouie Case-Based Sequential Ordering of Songs for Playlist Recommendation Claudio Baccigalupo, Enric Plaza
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Table of Contents A Comparative Study of Catalogue-Based Classification Petra Ferner Ontology-Driven Development of Convcrsational CBR Systems Hector Gömez-GaucMa, Belen Diaz-Agudo, Pedro Gonzalez- Calero Complexity Profiling for Informed Case-Base Editing Stewart Massie, Susan Craw. Nirmalie Wiratunga Unsupervised Feature Selection for Text Data Nirmalie Wiratunga, Robert Lothian, Stewart Massie Combining Case-Based and Similarity-Based Product Recommendation Armin Stahl On the Use of Selective Ensembles for Relevance Classification in Casc-Based Web Search Maurice Coyle, Barry Smyth What Evaluation Criteria Are Right for CCBR? Coiisidering Rank Quality Steven Bogaerts. David B. Leake Fast Case Retrieval Nets for Textual Data Sutanu Chakraborti, Robert Lothian, Nirmalie Wiratunga., Amandine Orecchioni, Stuart Watt Combining Multiple Similarity Metrics Using a Multicriteria Approach Luc Larnontagne, Irene Abi-Zeid Case Factory - Maintaining Experience to Learn Klaus-Dieter Althoff, Alexandre Hanft, Martin Schaaf Retrieval over Conceptual Structures Pablo Beltrdn-Ferruz, Belen Diaz-Agudo, Oscar Lagerquist An Analysis on Transformational Analogy: General Framework and Complexity Vithal Kuchibatla, Hector Munoz-Avila Discovering Knowledge About Key Sequences for Indexing Time Series Cascs in Medical Applications Peter Funk, Xiong Ning