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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

  • Stuart Walker
  • Cyndy Lumley
  • Neil McAuslane

Part of the CMR Workshop Series book series (CMRW)

Table of contents

  1. Front Matter
    Pages i-xviii
  2. Problems in the Acceptability of Foreign Clinical Data for Pharmaceuticals

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

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

    1. Front Matter
      Pages 199-199
    2. Luc Balant, Marianne Gex-Fabry, Androniki Balant-Gorgia
      Pages 201-217
    3. Jean-Marc Husson
      Pages 229-251
  5. Back Matter
    Pages 253-262

About this book

Introduction

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.

Keywords

clinical trial drug drug development metabolism research

Editors and affiliations

  • Stuart Walker
    • 1
  • Cyndy Lumley
    • 1
  • Neil McAuslane
    • 1
  1. 1.Centre for Medicines ResearchCarshalton, SurreyUK

Bibliographic information