高变异药物的生物等效性研究进展

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高变异药物的生物等效性研究进展

作者:刘东阳, 李丽, 江骥, 胡蓓

作者单位:中国医学科学院、中国协和医科大学,北京协和医院,临床药理中心,北京,100730

刊名:

中国临床药理学杂志

英文刊名:THE CHINESE JOURNAL OF CLINICAL PHARMACOLOGY

年,卷(期):2008,24(4)

1.Japan National Institute of Health Division of drugs,guideline for ioequivalence studies of generic drug products 2007

2.Health Canada,Ministry of Health,Guidance for Industry Conduct and analysis of bioavailability and bioequivalence studies-part A:oral dosage formulations used for systemic effects 2007

3.Medicines Control Council;Department of Health,Republic of South Africa Registration of medicines:biestudies 2007

mittee for Proprietary Medicinal Products (CPMP);The European Agency for the Evaluation of Medicinal Products (EMEA)Note for guidance on the investigation of bioavailability and bioequivalence 2007

5.Ceballos A;Cirri M;Maestrelli F Influence of formulation and process variables on in vitro release of theophylline from directly-compressed Eudragit matrix tablets 2005

6.Blume HH;Midha KK Bio-International 92,conference on bioavailability,bioequivalence,and pharmacokinetic studies 1993

7.Hauschke D;Kieser M;Diletti E Sample size determination for proving equivalence based on the ratio of two means for normally distributed data[外文期刊] 1999(1)

8.Pharsight Corporation WinNonLin Users Guide 2002

9.Midha KK;Shah VP;Singh GJP Conference report:bio-international 2005[外文期刊] 2007(4)

10.Applied Clinical Pharmacology Services (ACPS)Background Information for Advisory Committee Meeting On April 14,2004,Bioequivalence Requirements for Highly Variable Drugs and Drug Products 2004

11.Resenbaum SE Effect of variability in hepatic clearance on the bioequivalence parameters of a drug and its metabolite:simulations using a pharmacostatistical model 1998

12.Jackson AJ;Robbie G;Marroum P Metabolites and bioequivalence:past and present[外文期刊] 2004(10)

13.Kortekangas PC;Loyttyniemi E;Liukko-Sipi S Pooling of clodronate urinary excretion data:a new pharmacokinetic method to study drugs with highly variable gastrointestinal absorption[外文期刊] 1997(1)

14.Center for Drug Evaluation and Research (CDER);Food and Drug Administration (FDA)

Bioavailability and bioequivalence studies for orally administered drug products-general considerations 2007

15.Karalis V;Macheras P;Symillides M Geometric mean ratio-dependent scaled biceqnivalence limits with leveling-off properties[外文期刊] 2005(1)

variability considerations[外文期刊] 2004(10)

17.Tothfalusi L;Endrenyi L Limits for the scaled average bioeqnivalence of highly variable drags and drug products[外文期刊] 2003(3)

18.Tothfalusi L;Endrenyi L;Midha KK Scaling or wider bioequicalence limits for highly variable drugs and for the special case of Cmax 2003

19.Midha KK;Rawson MJ;Hubbard JW Bioeqnivalence:Switchability and scaling 1998

20.Boddy AW;Snikeris FC;Kringle RO An approach for widening the bioequivalence limits in the case of highly variable drugs 1995

21.Chen ML;Lesko LJ Individual bioequivalence revisited 2001

22.Center for Drug Evaluation and Research (CDER);Food and Drug Administration (FDA)Statistial approaches to establishing hioequivalence 2007

23.Center for Drug Evaluation and Research (CDER);Food and Drug Administration (FDA)Guidance for indnstry:bioavailability and bioequivalence studies for orally administered drug products-general considerations 2007

24.Patterson SD;Zariffa NMD;Montague TH Non -traditional study designs to demonstrate average bioeqnivalence for highly variable drug products[外文期刊] 2001(9)

25.Midha KK;Rawson MJ;Hubbard JW The bioequivalence of highly variable drugs and drug products[外文期刊] 2005(10)

1.黄钦.魏春敏.HUANG Qin.WEI Chun-min浅谈高变异药物的生物等效性研究[期刊论文]-中国临床药理学与治疗学2007,12(8)

2.王水强.赵建中.WANG Shui-qiang.ZHAO Jian-zhong生物等效性研究的一般原则与特殊问题[期刊论文]-中国临床药理学杂志2010,26(1)

3.涂洪谊.温明.TU Hong-yi.WEN Ming生物等效性评价及相关问题[期刊论文]-中国新药与临床杂志2008,27(5)

4.统计学在生物等效性研究中的意义[期刊论文]-中国临床药理学杂志2006,22(4)

5.杜军.DU Jun非等精度测量的等效性研究[期刊论文]-天津工程师范学院学报2010,20(3)

6.刘华.LIU Hua3×3设计中个体生物等效性评价的广义P-值法[期刊论文]-阜阳师范学院学报(自然科学版)2005,22(4)

7.吴世成生物等效性研究探讨[期刊论文]-科技信息2008(35)

8.李娟.谢海棠.郑青山生物等效性研究现状概述[期刊论文]-安徽医药2007,11(7)

9.金华.Jin Hua基于平均生存时间的两种分类方法的比较[期刊论文]-统计研究2008,25(1)

10.郑萍.胡敏燕.陈志良.张庆.江骥.胡蓓多剂量口服阿德福韦酯片剂在中国健康志愿者的药代动力学和安全性[会议论文]-2008

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