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About Drug safety evaluation
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
Detailed Information
| Author: | Shayne C. Gad |
|---|---|
| Publication Year: | 2002 |
| ISBN: | 9780471462996 |
| Pages: | 1019 |
| Language: | English |
| File Size: | 6.295 |
| Format: | |
| Price: | FREE |
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