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Title Design and analysis of animal studies in pharmaceutical development / edited by Shein-Chung Chow, Jen-pei Liu
Published New York, N.Y. : Marcel Dekker, 1998

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Description 1 online resource (x, 407 pages) : illustrations
Series Biostatistics (New York, N.Y.) ; 1.
Contents Cover -- Half Title -- Title Page -- Copyright Page -- Contents -- Series Introduction -- Preface -- Contributors -- 1. Introduction -- 2. Experimental Design Principles for Animal Studies in Pharmaceutical Development -- 3. Interval Estimation with Small Samples for Median Lethal Dose or Median Effective Dose -- 4. Principles in Statistical Testing in Randomized Toxicological Studies -- 5. Subchronic Toxicity Studies -- 6. Safety Assessment in Toxicological Studies: Proof of Safety Versus Proof of Hazard -- 7. The Design of Long-Term Carcinogenicity Studies -- 8. Analysis of Long-Term Carcinogenicity Studies -- 9. Design of Developmental and Reproductive Toxicology Studies -- 10. Analysis of Reproductive and Developmental Studies -- 11. The In Vitro Ames Tests -- 12. The In Vitro Chinese Hamster Ovary Cell Mutagenesis Studies -- Index
Summary This practical resource provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development - demonstrating the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products. Clarifying detailed presentations with real-world examples, Design and Analysis of Animals Studies in Pharmaceutical Development furnishes definitions, background information, and regulatory requirements ... discusses statistical designs and methods for bioassay ... describes techniques for estimating drug efficacy and lethal doses ... illustrates statistical concepts as well as design and analysis principles for toxicology studies ... shows how to assess carcinogenicity and teratology for drugs under development ... details methods of analysis for in vitro Ames tests and Chinese hamster ovary cell mutagenesis studies ... and more
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Pharmacy -- Research -- Statistical methods
Diseases -- Animal models.
Laboratory animals.
Drug Evaluation, Preclinical -- methods
Disease Models, Animal
Animals, Laboratory
Statistics as Topic -- methods
Toxicity Tests -- methods
MEDICAL -- Pharmacology.
Diseases -- Animal models
Laboratory animals
Pharmacy -- Research -- Statistical methods
Préparations pharmaceutiques -- Normes de référence.
Chimie pharmaceutique -- Méthodes.
Modèles animaux de maladie humaine.
Animaux de laboratoire.
Médicaments -- Conception.
Maladies -- Modèles animaux.
Thérapeutique expérimentale.
Form Electronic book
Author Chow, Shein-Chung, 1955-
Liu, Jen-pei, 1952-
ISBN 0585266476
9780585266473
9780429177392
0429177399