Drug safety evaluation PDF
1019 Pages·2002·6.295 MB·English
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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
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