个人房屋租赁合同书规范标准.pptx
合集下载
相关主题
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
Para-aminophenol derivatives • Acetaminophen
Indole and indene acetic acids • Indomethacin, sulindac
Heteroaryl acetic acids • Tolmetin, diclofenac, ketorolac
Ian M. Gralnek, M.D., MSHS
Assistant Professor of Medicine, Division of Digestive Diseases David Geffen School of Medicine at UCLA
5
Regulatory Overview
class are potency and pharmacokinetics
7
Classes of NSAIDS
Salicylic acid derivatives • Aspirin, sodium salicylate, choline magnesium trisalicylate, salsalate, diflunisal
Consumer Care Division
P-2
Agenda
Regulatory Overview
Naproxen
ADAPT Trial
Safety Evaluation
Clinical Pharmacology Clinical Studies Postmarketing Surveillance Observational Studies
Naproxen available in the United States since 1976
Prescription currently marketed by multiple manufacturers for the treatment of RA, OA, ankylosing spondylitis, gout, juvenile RA, dysmenorrhea, tendinitis, bursitis, and pain
Conclusions
3
Roche/Bayer Presenters and Responders
Presenters:
Leonard M. Baum, RPh
Vice President, Regulatory Affairs Bayer HealthCare
Martin H. Huber, M.D.
Bayer HealthCare
4
Baidu Nhomakorabea
Outside Experts
Kay Brune, M.D.
Professor and Chairman Department of Experimental and Clinical Pharmacology and Toxicology Friedrich-Alexander University Erlangen - Nuremberg
Vice President, Global Head Drug Safety Risk Management Hoffmann La-Roche Inc.
Responders:
Susan Sacks, Ph.D.
Global Head, Epidemiology Hoffmann La-Roche Inc.
Bharat Thakrar, Ph.D.
Senior Epidemiologist Hoffmann La-Roche Inc.
Ernst Weidmann, M.D.
Head, Global Safety
Bayer HealthCare
Steve Zlotnick, Pharm.D.
Director, Medical Affairs
Propionic acids • Naproxen, ibuprofen, flurbiprofen, ketoprofen, fenoprofen, oxaprozin
Anthranilic acids (fenamates) • Mefenamic acid, meclofenamic acid
Joint Meeting of the Arthritis and Drug Safety and Risk Management Advisory Committees
February 16-18, 2005
P-1
Leonard M. Baum, RPh
Vice President, Regulatory Affairs Bayer HealthCare
Multiple generic versions
6
Naproxen
Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), belongs to the chemical class propionic acid derivatives
Naproxen has anti-inflammatory, analgesic and antipyretic properties
Naproxen known to inhibit platelet aggregation The major differences between members of the NSAID
Aleve (OTC) approved in 1994
Currently marketed by Bayer HealthCare for temporary relief of minor aches and pains, and for the temporary reduction of fever
Enolic acids • Oxicams (piroxicam, meloxicam)
Alkanones • Nabumetone
Coxibs
• Celecoxib, valdecoxib, rofecoxib (withdrawn)
Source: Goodman and Gilman’s The Pharmacological Basis of Therapeutics, 10th edition
Indole and indene acetic acids • Indomethacin, sulindac
Heteroaryl acetic acids • Tolmetin, diclofenac, ketorolac
Ian M. Gralnek, M.D., MSHS
Assistant Professor of Medicine, Division of Digestive Diseases David Geffen School of Medicine at UCLA
5
Regulatory Overview
class are potency and pharmacokinetics
7
Classes of NSAIDS
Salicylic acid derivatives • Aspirin, sodium salicylate, choline magnesium trisalicylate, salsalate, diflunisal
Consumer Care Division
P-2
Agenda
Regulatory Overview
Naproxen
ADAPT Trial
Safety Evaluation
Clinical Pharmacology Clinical Studies Postmarketing Surveillance Observational Studies
Naproxen available in the United States since 1976
Prescription currently marketed by multiple manufacturers for the treatment of RA, OA, ankylosing spondylitis, gout, juvenile RA, dysmenorrhea, tendinitis, bursitis, and pain
Conclusions
3
Roche/Bayer Presenters and Responders
Presenters:
Leonard M. Baum, RPh
Vice President, Regulatory Affairs Bayer HealthCare
Martin H. Huber, M.D.
Bayer HealthCare
4
Baidu Nhomakorabea
Outside Experts
Kay Brune, M.D.
Professor and Chairman Department of Experimental and Clinical Pharmacology and Toxicology Friedrich-Alexander University Erlangen - Nuremberg
Vice President, Global Head Drug Safety Risk Management Hoffmann La-Roche Inc.
Responders:
Susan Sacks, Ph.D.
Global Head, Epidemiology Hoffmann La-Roche Inc.
Bharat Thakrar, Ph.D.
Senior Epidemiologist Hoffmann La-Roche Inc.
Ernst Weidmann, M.D.
Head, Global Safety
Bayer HealthCare
Steve Zlotnick, Pharm.D.
Director, Medical Affairs
Propionic acids • Naproxen, ibuprofen, flurbiprofen, ketoprofen, fenoprofen, oxaprozin
Anthranilic acids (fenamates) • Mefenamic acid, meclofenamic acid
Joint Meeting of the Arthritis and Drug Safety and Risk Management Advisory Committees
February 16-18, 2005
P-1
Leonard M. Baum, RPh
Vice President, Regulatory Affairs Bayer HealthCare
Multiple generic versions
6
Naproxen
Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), belongs to the chemical class propionic acid derivatives
Naproxen has anti-inflammatory, analgesic and antipyretic properties
Naproxen known to inhibit platelet aggregation The major differences between members of the NSAID
Aleve (OTC) approved in 1994
Currently marketed by Bayer HealthCare for temporary relief of minor aches and pains, and for the temporary reduction of fever
Enolic acids • Oxicams (piroxicam, meloxicam)
Alkanones • Nabumetone
Coxibs
• Celecoxib, valdecoxib, rofecoxib (withdrawn)
Source: Goodman and Gilman’s The Pharmacological Basis of Therapeutics, 10th edition