Toxicological testing handbook: principles, applications, and data interpretation

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 stands as a complete source of guidance for professionals developing toxicology data, evaluating toxicology studies, and performing risk assessment...addresses topics including species selection, dose level, routes of exposure, and statistical evaluation for toxicological studies...helps readers design product safety studies and facilitate regulatory approval...contains information that is pertinent for individuals responsible for registering products in overseas markets...and provides guidance on how to evaluate the quality of a CRO prior to hiring.

Revised edition of: Toxicology testing handbook : principles, applications, and data interpretation / edited by David Jacobson-Kram, Kit A. Keller. c2001.

Regulatory toxicology testing: laboratories and good laboratory practices / Linda J. Frederick -- Laboratory animals and in vitro test systems used in regulatory toxicology / Kit A. Keller -- Safety pharmacology / William S. Redfern and Ian D. Wakefield -- Metabolism and toxicokinetics / J. Caroline English -- Toxicologic pathology assessment / Lynda L. Lanning -- Acute toxicology / Elmer J. Rauckman and Andrew I. Soiefer -- Multidose general toxicology studies / Kit A. Keller and Christopher Banks -- Genetic toxicology / Donald L. Putman [and others] -- Carcinogenicity studies / Abigail C. Jacobs -- Juvenile animal toxicology studies / Kok Wah Hew -- Developmental and reproductive toxicology / Kit A. Keller -- Neurotoxicology testing / Kathleen C. Raffaele and Walter P. Weisenburger -- Toxicological assessment of the immune system / Dori R. Germolec [and others] -- Inhalation and pulmonary toxicity studies / Raymond M. David -- Cancer risk assessment of environmental agents: approaches to the incorporation and analysis of new scientific information / William H. Farland, William P. Wood and Kery L. Dearfield -- Nonclinical safety testing of pharmaceuticals / Amy L. ellis and Kenne…