(Ebook) Drug safety evaluation by Shayne C. Gad ISBN 9780471407270, 9780471459293, 9780471462996, 0471407275, 0471459291, 0471462993

(Ebook) Drug safety evaluation by Shayne C. Gad ISBN 9780471407270, 9780471459293, 9780471462996, 0471407275, 0471459291, 0471462993

Strategy and phasing for drug safety evaluation in the discovery and development of pharmaceuticals -- Regulation of human pharmaceutical safety -- Information sources: Building and maintaining data files -- screens in safety and hazard assessment -- Acute toxicity testing in drug safety evaluation -- Genotoxicity -- Subchronic and chronic toxicity studies -- Developmental and reproductive toxicity testing -- Carcinogenicity studies -- Safety assessment of inhalant drugs -- Irritation and local tissue tolerance in pharmaceutical safety assessment -- Special concerns for the preclinical evaluation of biotechnology products -- Formulations, routes, and dosage designs -- Occupational toxicology in the pharmaceutical industry -- Immunotoxicology in pharmaceutical development -- Large animal studies -- The application of in vitro techniques in drug safety assessment -- Pharmacokinetics and toxicokinetics in drug safety evaluation -- Safety pharmacology -- Evaluation of human tolerance and safety in clinical trials: Phase I and beyond -- Postmarketing safety evaluation: Monitoring, assessing, and reporting of adverse drug responses (ADRs) -- Statistics in pharmaceutical safety assessment