Ethnicity in Drug Development and Therapeutics
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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CLINICAL EVIDENCE OF ETHNIC AND RACIAL
ETHNIC AND RACIAL DIFFERENCES
NONGENETIC BASIS FOR ETHNIC
THE IMPACT OF PHARMACOGENOMICS
PHARMACOKINETIC ANALYSIS OF ETHNIC
ETHNIC REPRESENTATION IN CLINICAL
RECRUITMENT AND RETENTION OF MINORITY
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absorption acid African Americans alcohol alleles antipyrine Asians Bertilsson bioavailability cancer Caucasians clearance Clin Pharmacol Ther clinical research clinical trials compounds cultural cyclosporine CYP2Cl9 CYP2D6 gene CYP2D6 genotype debrisoquine deﬁciency deﬁned dextromethorphan diabetes diazepam diet dietary differences in drug disease dosage dose drug development drug metabolism effects efﬁcacy enzyme enzyme activity ethnic and racial ethnic differences ethnic groups ethnic/racial example factors frequency genetic polymorphisms genotype grapefruit juice guidelines haloperidol hepatic herbal Hispanic hydroxylation hypertension identiﬁed increased individuals inﬂuence inhibitors intake Japan Japanese lithium medications mephenytoin metabolite metabolizer phenotype minority mutations ng-h/mL nifedipine nortriptyline oxidation participation in clinical patients pharmaceutical pharmacodynamic PHARMACOKINETIC PARAMETERS phenotype plasma levels poor metabolizers prevalence propranolol Psychiatry racial differences receptor recruitment reduced haloperidol region renal response ritonavir signiﬁcant signiﬁcantly higher smoking sparteine speciﬁc subjects tardive dyskinesia therapeutic thiopurine thiopurine methyltransferase tion treatment ultrarapid metabolizers variability vegetarians vitamin women