Statistics in the pharmaceutical industry
著者
書誌事項
Statistics in the pharmaceutical industry
（Statistics : textbooks and monographs, v. 140）
Marcel Dekker, c1994
2nd ed., rev. and expanded
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
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.
目次
- 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.
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