The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

By: Cyndy E. Lumley (Editor), Stuart R. Walker (Editor), Neil McAuslane (Editor)

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There is currently limited acceptance of foreign clinical data by regulatory authorities, although the reasons for repeating studies are poorly defined. There are some proven genetic differences in drug metabolism and elimination which occur with varying frequencies in different populations. In addition, there are differences in culture, environment and medical practice which can impact on drug reponsiveness. This book, a further edition in the CMR Workshop Series, reviews the proceedings of a workshop held in London in July 1993 to address these issues. The contributors review the current situation, address the scientific basis for repeating clinical trials in different ethnic groups, consider specific examples, and assess the relevance of interethnic and environmental differences in responsiveness for drug development.

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Non-Fiction Medicine Other Branches of Medicine Pharmacology Society & Culture Social Groups Ethnic Studies Nursing & Ancillary Services Pharmacy & Dispensing Medicine in General Health Systems & Services Medical Administration & Management

Public Health & Preventive Medicine

Preface
Notes on Contributors
Acceptability of foreign data: genetic, cultural and environmental differences - do they matter?	p. 3
Genetic polymorphisms in drug metabolism: clinical implications and consequences in ADME studies	p. 13
Inter-ethnic differences in dose-response studies	p. 27
Evaluation methods for clinical trials of drugs in Japan which may affect ethnic differences	p. 49
The top 50 drugs in the UK and Japan: why are they so different?	p. 63
Ethnic differences in response to pharmaceuticals across Europe	p. 89
Medical practice differences between Europe, the United States and Japan	p. 97
A survey of current practices in the US regarding minorities and gender: the pharmaceutical perspective	p. 107
Current approaches to global drug development from a European perspective	p. 115
Current approaches to global drug development from a Japanese perspective	p. 131
Summary of Session I	p. 139
The acceptability of foreign data in the registration of new medicines - Health Protection Branch viewpoint	p. 147
The acceptability of foreign data in the registration of new medicines	p. 155
Ethnic effects on pharmacokinetic parameters	p. 161
A comparison of the clinical evaluation of medicines in Japanese and Caucasian populations	p. 179
Current status of CMR survey on inter-ethnic differences in clinical responsiveness	p. 187
Implications for the design and interpretation of Phase III clinical trials	p. 201
Dose-utility relationships in diverse populations: ethnic, age, gender and cultural factors in efficacy and safety	p. 219
General discussion and concluding remarks	p. 229
Appendix - Workshop participants	p. 253
Index	p. 257
Table of Contents provided by Blackwell. All Rights Reserved.

The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

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