Ethnicity in Drug Development and Therapeutics

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Cambridge University Press, Jun 16, 2011 - Medical - 152 pages
This book was first published in 2002. It presents an overview of ethnic and racial differences in response to medications and offers insight into the genetic and non-genetic reasons for these differences. The roles of pharmacogenomics and pharmacogenetics in drug development, regulatory aspects of representing minorities in clinical trials, as well as NIH, ICH and FDA guidelines as they pertain to these issues are examined in detail. Finally, various strategies to increase recruitment and retention of minority populations in clinical trials are considered.
 

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Contents

CLINICAL EVIDENCE OF ETHNIC AND RACIAL
1
ETHNIC AND RACIAL DIFFERENCES
27
NONGENETIC BASIS FOR ETHNIC
65
THE IMPACT OF PHARMACOGENOMICS
89
PHARMACOKINETIC ANALYSIS OF ETHNIC
95
ETHNIC REPRESENTATION IN CLINICAL
101
RECRUITMENT AND RETENTION OF MINORITY
115
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