Front cover image for Drug safety evaluation

Drug safety evaluation

A comprehensive safety guide to all aspects of the drug development process. Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated
eBook, English, 2002
J. Wiley, New York, 2002
1 online resource (ix, 1007 pages) : illustrations
9780471459293, 9780471462996, 0471459291, 0471462993
53121814
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
Electronic reproduction, [Place of publication not identified], HathiTrust Digital Library, 2010