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The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

Proceedings of a Workshop held at The Medical Society of London, UK, 7th and 8th July, 1993

  • Conference proceedings
  • © 1994

Overview

Editors:
  1. Stuart Walker

    1. Centre for Medicines Research, Carshalton, Surrey, UK

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  2. Cyndy Lumley

    1. Centre for Medicines Research, Carshalton, Surrey, UK

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  3. Neil McAuslane

    1. Centre for Medicines Research, Carshalton, Surrey, UK

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Part of the book series: Centre for Medicines Research Workshop (CMRW)

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Table of contents (19 papers)

  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

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

      • Douwe D. Breimer
      Pages 13-26

    4. Inter-ethnic differences in dose-response studies

      • Luc P. Balant, Pierre Bechtel
      Pages 27-48

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

      • Chikayuki Naito
      Pages 49-62

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

      • Kazunori Hirokawa, Colin T. Dollery
      Pages 63-88

    7. Ethnic differences in response to pharmaceuticals across Europe

      • Marisa Papaluca
      Pages 89-96

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

      • John Henderson
      Pages 97-106

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

      • Lionel D. Edwards
      Pages 107-114

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

      • John Patterson
      Pages 115-130

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

      • Brian A. Gennery
      Pages 131-138

    12. Summary of Session I

      • Trevor Jones
      Pages 139-143

  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

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

      • Jens Schou, Marisa Papaluca
      Pages 155-159

    4. Ethnic effects on pharmacokinetic parameters

      • Chikayuki Naito
      Pages 161-177

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

      • Etienne Labbe
      Pages 179-186

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

      • Christine Harvey, Neil McAuslane, Cyndy Lumley, Stuart Walker
      Pages 187-197

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

    1. Front Matter

      Pages 199-199
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Keywords

About this book

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.

Editors and Affiliations

  • Centre for Medicines Research, Carshalton, Surrey, UK

    Stuart Walker, Cyndy Lumley, Neil McAuslane

Bibliographic Information

  • Book Title: The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

  • Book Subtitle: Proceedings of a Workshop held at The Medical Society of London, UK, 7th and 8th July, 1993

  • Editors: Stuart Walker, Cyndy Lumley, Neil McAuslane

  • Series Title: Centre for Medicines Research Workshop

  • DOI: https://doi.org/10.1007/978-94-011-1420-2

  • Publisher: Springer Dordrecht

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer Science+Business Media Dordrecht 1994

  • Hardcover ISBN: 978-0-7923-8843-2Published: 30 April 1994

  • Softcover ISBN: 978-94-010-4621-3Published: 20 October 2012

  • eBook ISBN: 978-94-011-1420-2Published: 06 December 2012

  • Edition Number: 1

  • Number of Pages: XVIII, 262

  • Topics: Pharmacology/Toxicology, Public Health

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