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Название: Drug Safety Evaluation
Автор: Gad S.C.
Gad brings some 25 years of experience in toxicology, drug development, and risk assessment to this practical guide for those in the pharmaceutical and biotechnology industries responsible for ensuring the safety of drugs and biologics to patients, health care providers, manufacturers of medicinal products, and those concerned with safety evaluation. The text addresses safety assessment as an integral part of the development of new drugs and therapeutics, specific approaches to evaluating hazards, problems that are encountered and their solutions, and scientific and philosophical bases for the evaluation of specific concerns to provide an understanding and guidance for approaching new problems. A sampling of topics: acute toxicity testing, genotoxicity, carcinogenicity studies, safety assessment of inhalant drugs, occupational toxicology in the pharmaceutical industry, large animal studies, evaluation of human tolerance and safety in clinical trials.