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Item Details
Title: 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
By: S.R. Walker (Editor), Cyndy E. Lumley (Editor), Neil McAuslane (Editor)
Format: Paperback

List price: £54.99


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ISBN 10: 9401046212
ISBN 13: 9789401046213
Publisher: SPRINGER
Pub. date: 20 October, 2012
Edition: Softcover reprint of the original 1st ed. 1994
Series: Centre for Medicines Research Workshop
Pages: 262
Synopsis: 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.
Illustrations: biography
Publication: Netherlands
Imprint: Springer
Returns: Returnable
Some other items by this author:
BRITAIN'S TOWER BLOCKS (PB)
BUILDING QUALITY MEASURES INTO THE REGULATORY REVIEW PROCESS (PB)
FULFILLING THE POTENTIAL OF ELECTRONIC INTERACTION BETWEEN THE PHARMACEUTICAL INDUSTRY AND REGULATORS (PB)
IMPROVING THE REGULATORY REVIEW PROCESS (PB)
IMPROVING THE REGULATORY REVIEW PROCESS: ASSESSING PERFORMANCE AND SETTING TARGETS (PB)
INTERNATIONAL MEDICINES REGULATIONS (PB)
ISSUES OF CONCERN IN CLINICAL DEVELOPMENT (PB)
MEDICINES AND RISK/BENEFIT DECISIONS (PB)
MONITORING FOR ADVERSE DRUG REACTIONS (HB)
PROBLEM HOUSING ESTATES IN BRITAIN (PB)
QUALITY OF LIFE ASSESSMENT: KEY ISSUES IN THE 1990S (PB)
SAFETY EVALUATION OF BIOTECHNOLOGICALLY-DERIVED PHARMACEUTICALS (HB)
SAFETY EVALUATION OF BIOTECHNOLOGICALLY-DERIVED PHARMACEUTICALS (PB)
THE RELEVANCE OF ETHNIC FACTORS IN THE CLINICAL EVALUATION OF MEDICINES (HB)
THE TIMING OF TOXICOLOGICAL STUDIES TO SUPPORT CLINICAL TRIALS (PB)
TRENDS AND CHANGES IN DRUG RESEARCH AND DEVELOPMENT (PB)

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