Ethnicity in Drug Development and Therapeutics

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.