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 ... 1993 (Centre for Medicines Research Workshop) - Softcover
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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.
Reseña del editor:
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.
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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- VerlagSpringer
- Erscheinungsdatum2012
- ISBN 10 9401046212
- ISBN 13 9789401046213
- EinbandTapa blanda
- Anzahl der Seiten284
- HerausgeberWalker S.R., Lumley Cynthia, McAuslane N.
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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
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Springer Netherlands
(2012)
ISBN 10: 9401046212
ISBN 13: 9789401046213
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Buchbeschreibung Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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. Artikel-Nr. 9789401046213
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