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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 (Paperback, Softcover reprint of the original 1st ed. 1994)
Loot Price: R1,598
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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 (Paperback, Softcover reprint of the original 1st ed. 1994)
Series: Centre for Medicines Research Workshop
Expected to ship within 10 - 15 working days
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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."
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