The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

1. Front Matter

   Pages i-xviii

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2. Problems in the Acceptability of Foreign Clinical Data for Pharmaceuticals

   1. Front Matter

      Pages 1-1

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   2. Acceptability of foreign data: genetic, cultural and environmental differences - do they matter?

      • Lionel D. Edwards

      Pages 3-11

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   3. Genetic polymorphisms in drug metabolism: clinical implications and consequences in ADME studies

      • Douwe D. Breimer

      Pages 13-26

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   4. Inter-ethnic differences in dose-response studies

      • Luc P. Balant, Pierre Bechtel

      Pages 27-48

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   5. Evaluation methods for clinical trials of drugs in Japan which may affect ethnic differences

      • Chikayuki Naito

      Pages 49-62

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   6. The top 50 drugs in the UK and Japan: why are they so different?

      • Kazunori Hirokawa, Colin T. Dollery

      Pages 63-88

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   7. Ethnic differences in response to pharmaceuticals across Europe

      • Marisa Papaluca

      Pages 89-96

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   8. Medical practice differences between Europe, the United States and Japan

      • John Henderson

      Pages 97-106

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   9. A survey of current practices in the US regarding minorities and gender: the pharmaceutical perspective

      • Lionel D. Edwards

      Pages 107-114

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   10. Current approaches to global drug development from a European perspective

       • John Patterson

       Pages 115-130

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   11. Current approaches to global drug development from a Japanese perspective

       • Brian A. Gennery

       Pages 131-138

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   12. Summary of Session I

       • Trevor Jones

       Pages 139-143

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3. The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

   1. Front Matter

      Pages 145-145

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   2. The acceptability of foreign data in the registration of new medicines - Health Protection Branch viewpoint

      • Katherine Voith

      Pages 147-154

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   3. The acceptability of foreign data in the registration of new medicines

      • Jens Schou, Marisa Papaluca

      Pages 155-159

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   4. Ethnic effects on pharmacokinetic parameters

      • Chikayuki Naito

      Pages 161-177

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   5. A comparison of the clinical evaluation of medicines in Japanese and Caucasian populations

      • Etienne Labbe

      Pages 179-186

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   6. Current status of CMR survey on inter-ethnic differences in clinical responsiveness

      • Christine Harvey, Neil McAuslane, Cyndy Lumley, Stuart Walker

      Pages 187-197

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4. The Relevance of Inter-Ethnic Differences for Drug Development and Registration

   1. Front Matter

      Pages 199-199

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For a research-based pharmaceutical company to be successful in the 1990s. it must have a strategic plan for the global development of new chemical entities. Global development can be defined as an attempt to reach all major markets as rapidly as possible and for many companies these will include the United States. Japan. Germany. France. Italy. UK and Canada. which together represent approximately 85% of the pharmaceutical market in the developed world. The mutual acceptance of foreign clinical data would reduce the time and resources required to develop a new medicine for the international market by eliminating the requirement for the routine repetition of clinical studies in local populations. In Japan this has been largely based on the belief that genetic differences in respon­ siveness may result in a different benefit/risk assessment for a new mediCine. while requests in Europe and the United States for local data relate mainly to methodological and cultural considerations. The importance of this issue has been recognised internationally as it was one of the topics discussed at the International Conference on Harmonisation in Orlando (October 1993) and it is currently on the programme for ICH3 which will be convened in Yokohama in Japan in November 1995.

• clinical trial
• drug
• drug development
• metabolism
• research

• Centre for Medicines Research, Carshalton, Surrey, UK

  Stuart Walker, Cyndy Lumley, Neil McAuslane

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