Centre for Medicines Research Workshop

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

Editors: Walker, S.R., Lumley, Cynthia, McAuslane, N. (Eds.)

Free Preview

Buy this book

eBook $59.99
price for USA in USD (gross)
  • ISBN 978-94-011-1420-2
  • Digitally watermarked, DRM-free
  • Included format: PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Softcover $79.99
price for USA in USD
  • ISBN 978-94-010-4621-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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.

Table of contents (19 chapters)

Table of contents (19 chapters)
  • Acceptability of foreign data: genetic, cultural and environmental differences - do they matter?

    Edwards, Lionel D.

    Pages 3-11

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

    Breimer, Douwe D.

    Pages 13-26

  • Inter-ethnic differences in dose-response studies

    Balant, Luc P. (et al.)

    Pages 27-48

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

    Naito, Chikayuki

    Pages 49-62

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

    Hirokawa, Kazunori (et al.)

    Pages 63-88

Buy this book

eBook $59.99
price for USA in USD (gross)
  • ISBN 978-94-011-1420-2
  • Digitally watermarked, DRM-free
  • Included format: PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Softcover $79.99
price for USA in USD
  • ISBN 978-94-010-4621-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Loading...

Recommended for you

Loading...

Bibliographic Information

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
  • S.R. Walker
  • Cynthia Lumley
  • N. McAuslane
Series Title
Centre for Medicines Research Workshop
Copyright
1994
Publisher
Springer Netherlands
Copyright Holder
Springer Science+Business Media Dordrecht
eBook ISBN
978-94-011-1420-2
DOI
10.1007/978-94-011-1420-2
Softcover ISBN
978-94-010-4621-3
Edition Number
1
Number of Pages
XVIII, 262
Topics