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Design and Analysis of Animal Studies in Pharmaceutical Development

Shein-Chung Chow Jen-pei Liu



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CRC Press
30 June 2020
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:   CRC Press
Country of Publication:   United Kingdom
Dimensions:   Height: 229mm,  Width: 152mm, 
Weight:   776g
ISBN:   9780367579388
ISBN 10:   0367579383
Pages:   408
Publication Date:   30 June 2020
Audience:   College/higher education ,  Primary
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

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