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Genre/Form: | Electronic books |
---|---|
Additional Physical Format: | Print version: Gad, Shayne C., 1948- Drug safety evaluation. New York : J. Wiley, 2002 (DLC) 2001046953 (OCoLC)48223708 |
Material Type: | Document, Internet resource |
Document Type: | Internet Resource, Computer File |
All Authors / Contributors: |
Shayne C Gad |
ISBN: | 0471459291 9780471459293 0471462993 9780471462996 |
OCLC Number: | 53121814 |
Reproduction Notes: | Electronic reproduction. [Place of publication not identified] : HathiTrust Digital Library, 2010. MiAaHDL |
Description: | 1 online resource (ix, 1007 pages) : illustrations |
Details: | Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002. |
Contents: | 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. |
Responsibility: | Shayne C. Gad. |
More information: |
Abstract:
Reviews
Publisher Synopsis
"For toxicologic pathologists, this book is the most useful as a reference book in a departmental library." (Veterinary Pathology, November 2004) "Gad brings...25 years of experience...to this practical guide..." (SciTech Book News, Vol. 26, No. 2, June 2002) "...offers an accumulation of facts and knowledge of a highly specialized and intense industry from an individual who has been successful in innovations and quality assurance..." (Veterinary and Human Toxicology, Vol. 45, No. 1, February 2003) "...it is a substantial book and accordingly should be considered a definitive reference work in this branch of toxicology." (Journal of Applied Toxicology, March April 2003) "...a definitive guide for those in the pharmaceutical industry who need to know how their products are evaluated and approved." (Business Horizons, January February 2003) "This book provides excellent treatise on drug safety evaluation...an excellent guide and reference..." (Pharmaceutical Research, Vol. 20, No. 6, June 2003) Read more...


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Related Subjects:(22)
- Drugs -- Toxicology.
- Drugs -- Testing.
- Pharmacovigilance.
- Drug monitoring.
- Drugs -- Side effects -- Reporting.
- Drug Evaluation, Preclinical
- Drug Evaluation
- Product Surveillance, Postmarketing
- United States
- Clinical Trials as Topic
- Drug Monitoring
- Pharmacovigilance
- Médicaments -- Toxicologie.
- Médicaments -- Essais cliniques.
- MEDICAL -- Drug Guides.
- MEDICAL -- Pharmacology.
- MEDICAL -- Pharmacy.
- MEDICAL -- Nursing -- Pharmacology.
- Évaluation préclinique médicament.
- Médicaments -- Toxicologie -- Évaluation.
- Médicaments -- Tests de toxicité.
- Pharmacology pharmaceutical medicine.