Design and Analysis of Animal Studies in Pharmaceutical Development

Shein-Chung Chow, Jen-pei Liu

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English

Marcel Dekker Inc
15 January 1998

Clinical trials; Epidemiology & medical statistics; Pharmacology; Veterinary medicine: laboratory animals; Probability & statistics; Zoology & animal sciences; Pharmaceutical technology

Series: Chapman & Hall/CRC Biostatistics Series

Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for

animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples.

Edited by: Shein-Chung Chow, Jen-pei Liu
Imprint: Marcel Dekker Inc
Country of Publication: United States
Volume: v. 1
Dimensions: Height: 280mm, Width: 210mm, Spine: 25mm
Weight: 771g
ISBN: 9780824701307
ISBN 10: 0824701305
Series: Chapman & Hall/CRC Biostatistics Series
Pages: 420
Publication Date: 15 January 1998
Audience: Professional and scholarly , Professional and scholarly , Undergraduate , Undergraduate
Format: Hardback
Publisher's Status: Active

Experimental design principles for animal studies in pharmaceutical development; interval estimation with small samples for Median Lethal Dose (LD50) or Median Effective Dose (ED50); principles in statistical testing in randomized toxicological studies; subacute toxicity studies - proof of safety versus proof of hazard; design of long-term carcinogenicity studies; analysis of long-term carcinogenicity studies; design of reproductive studies; analysis of reproductive and development studies; the in vitro Ames tests; the in vitro Chinese hamster ovary cell mutagenesis studies.

Shein-Chung Chow, Jen-pei Liu

Reviews for Design and Analysis of Animal Studies in Pharmaceutical Development

"". . .This book series will provide comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics. . .A well-balanced summary will be given of current and recently developed statistical methods and interpretations for both statisticians and researchers/scientists with minimal statistical knowledge who are engaged in applied biostatistics. The series is committed to providing easy-to-understand state-of-the-art references and textbooks. In each volume statistical concepts and methodologies will be illustrated with real examples. "" ---Shein-Chung Chow, Series Editor "". . .a fine overview of material that an industrial statistician will need to know when seeking employment in preclinical areas of pharmaceutical research. "" ---Technometrics