Statistics In the Pharmaceutical Industry, 3rd Edition
Marcel Dekker Inc (Verlag)
978-0-8247-9073-8 (ISBN)
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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.
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.
| Erscheint lt. Verlag | 17.11.1993 |
|---|---|
| Reihe/Serie | Chapman & Hall/CRC Biostatistics Series |
| Verlagsort | New York |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Gewicht | 862 g |
| Themenwelt | Mathematik / Informatik ► Mathematik ► Statistik |
| Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie | |
| Technik | |
| ISBN-10 | 0-8247-9073-1 / 0824790731 |
| ISBN-13 | 978-0-8247-9073-8 / 9780824790738 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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