Design and Analysis of Animal Studies in Pharmaceutical Development

Shein-Chung Chow, Jen-pei Liu

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English

Chapman & Hall/CRC
30 June 2020

Clinical trials; 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: Chapman & Hall/CRC
Country of Publication: United Kingdom
Dimensions: Height: 229mm, Width: 152mm,
Weight: 780g
ISBN: 9780367579388
ISBN 10: 0367579383
Series: Chapman & Hall/CRC Biostatistics Series
Pages: 408
Publication Date: 30 June 2020
Audience: Professional and scholarly , Undergraduate
Format: Paperback
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