ABSTRACT
"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 examp
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.
