This book is essentially about ‘Regulatory Toxicology’ – test methods and procedures required for generating data for submission to regulatory authorities. The introductory chapter gives a brief overview of various toxicity studies conducted as per Good Laboratory practices. Important considerations in toxicology testing have been outlined followed by a brief account of fundamental aspects of toxicity testing, animal husbandry, animal welfare and animal alternatives. The book also covers a wide range of experimental procedures including clinical and morphological studies, skin sensitization, teratogenicity, neurotoxicity and carcinogenicity studies, clinical and target organ pathology, inhalation toxicity, mutagenicity and statistical methods. Lastly, there is a chapter on how to manage a GP facility making this book useful for scientific and technical personnel involved in generating data required for registration of products.

Preface / Acknowledgements / Contributors / Abbreviations / Introduction / Important Considerations in Toxicology Testing / Fundamental Aspects of Toxicity Testing – A Brief Account / Animal Husbandry and Animal Welfare / Animal Alternatives / Practical Considerations in Toxicology Testing / Inhalation Toxicity Testing / Mutagenicity – An Overview / Clinical Pathology / Target Organ Pathology / Statistical Methods in Regulatory Toxicology / Managing a GLP Test Facility: Challenges and Clues / Colour Plates / Index.

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