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.
Table of Contents
Regulatory Toxicology Testing: Laboratories and Good Laboratory Practices. Laboratory Animals and In Vitro Test Systems Used in Regulatory Toxicology. Metabolism and Toxicokinetics. Toxicologic Pathology Assessment. Acute Toxicology. Multidose General Toxicology Studies. Genetic Toxicology. Carcinogenicity Studies. Juvenile Animal Toxicology Studies. Developmental and Reproductive Toxicology. Neurotoxicology Testing. Toxicological Assessment of the Immune System. Inhalation and Pulmonary Toxicity Studies. Cancer Risk Assessment. Nonclinical Safety Testing of Pharmaceuticals. Health Risk Assessment Strategies in the Food and Cosmetic Industry.
David Jacobson-Kram, Kit A. Keller