Design and Analysis of Animal Studies in Pharmaceutical Development

Shein-Chung Chow, Jen-pei Liu

". . .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

• 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.