Ethnicity In Drug Development And Therapeutics

Description: 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.

Contents: Foreword; Preface; References; 1. Clinical evidence of ethnic and racial differences in drug pharmacodynamics and pharmacokinetics; 2. Ethnic and racial differences in pharmacokinetics of drug metabolism; 3. Ethnic and racial differences in the pharmacokinetics of drugs: absorption, distribution, elimination; 4. Non-genetic basis for ethnic and racial differences in pharmacokinetic parameters; 5. The impact of pharmacokinetics on drug development; 6. Pharmacokinetic analysis of ethnic groups using population methods; 7. Ethnic representation in clinical research and foreign market penetration: regulatory aspects; 8. Recruitment and retention of minority study volunteers.