Introduction to the evolution of pharmaceutical products-- statistical review and evaluation of animal tumorigenicity studies-- uses of bioassay in drug development - dose-response relationships-- the FDA and the IND/NDA statistical review process-- clinical trial designs-- selecting patients for clinical trial-- statistical aspects of cancer clinical trials-- antiepileptic drug development program - a collaboration of government and industry-- design and analysis of clinical trials of analgesic drugs-- crossover designs in medical research-- statistical considerations in clinical trials of AIDS patients-- bioavailability studies-- the wonders of placebo-- interim analysis-- postmarketing studies and adverse drug experiences - the role of epidemiology-- the role of contract research organizations in clinical research in the pharmaceutical industry-- documenting the results of a clinical study-- data quality assurance-- managing CANDA submissions in the 1990s-- quality control-- stability of drugs-- when and how to do multiple comparisons-- adjustment of P-values for multiplicities of intercorrelating symptoms-- screening compounds for clinically active drugs-- survey of statisticians in the pharmaceutical industry.
(source: Nielsen Book Data)
This rewritten and updated second edition provides comprehensive information on the wide-ranging applications of statistics in the pharmacological field. Focusing on practical aspects, it sets out to bridge the gap between industry and academia. Reflecting the changes that have taken place since publication of the first edition, this volume covers new topics such as: cancer clinical trials, clinical trials of AIDS patients and animal tumorigenicity studies; the development of antiepileptic drugs; the role of epidemiology in postmarketing trials and adverse drug experience; computer-assisted new drug application (CANDA) submissions; contract research organizations; interim analysis in clinical trials; and room-temperature tests for the stability of drugs. This work is intended as: a reference for statisticians, biostatisticians, pharmacologists, administrators, managers, and scientists in the pharmaceutical industry; and a text for graduate students taking courses in applied statistics or pharmaceutical statistics. (source: Nielsen Book Data)