Toxicological Testing Handbook 2e

Furnishing essential data on all areas of toxicity testing, this Second Edition provides guidance on the design and evaluation of product safety studies to help ensure regulatory acceptance. Every chapter highlights regulatory requirements specific to the United States, Europe, and Japan, and in addition to expanded information on data interpretation, hazard assessment, carcinogenicity studies, and Good Laboratory Practices, new chapters regarding safety pharmacology, juvenile studies, the health safety assessment of pharmaceuticals, and health assessment strategies in the food and cosmetic industry have been added to reflect changes to regulatory requirements. Toxicological Testing Handbook, Second Edition is a must-have reference for individuals responsible for assuring the safety of new pharmaceutical, biotechnical, and chemical products and materials. This source Ë stands as a complete source of guidance for professionals developing toxicology data, evaluating toxicology studies, and performing risk assessment Ë addresses topics including species selection, dose level, routes of exposure, and statistical evaluation for toxicological studies Ë helps readers design product safety studies and facilitate regulatory approval Ë contains information that is pertinent for individuals responsible for registering products in overseas markets Ë provides guidance on how to evaluate the quality of a CRO prior to hiring