Teratogenicity Testing Methods and Protocols [Paperback]

Teratology is the study of chemical-induced birth defects. This book is a comprehensive guide to the procedures and methods commonly employed in the safety testing of all classes of chemical for teratogenicity (also referred to as embryotoxicity, developmental toxicity or prenatal toxicity). The various international regulatory requirements are explained in detail, in order that the reader may perform all of the necessary studies for the successful registration or marketing authorisation of a new pharmaceutical, industrial chemical, crop protection product or food additive. Written in the highly successful Methods in Molecular Biology series format, each chapter gives clear complete instructions on how to perform the task in hand. The authors are respected experts in their field, all with hands-on experience of the procedures described. Teratogenicity Testing: Methods and Protocols gives crucial guidance and tips on how to deal with unexpected results and overcome regulatory difficulties.

1. The ICH S5(R2) Guideline for the Testing of Medicinal Agents

L. David Wise

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2. Non-Clinical Reproductive Toxicity Testing Requirements for Drugs, Pesticides, and Industrial Chemicals in India and China

K.S. Rao and Jing Dong

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3. The Developmental Toxicity Testing of Biologics

Keith P Hazelden

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4. The OECD Guidelines for the Testing of Chemicals and Pesticides

Jochen Buschmann

Steve Barton

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