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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 inter-ethnic and
environmental differences in responsiveness for drug development.
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