Drug safety evaluation (eBook, 2002) [WorldCat.org]
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Drug safety evaluation

Drug safety evaluation

Author: Shayne C Gad
Publisher: New York : J. Wiley, 2002.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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.

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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
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:


Covers a wide variety of topics, including: acute toxicity testing in pharmaceutical safety evaluation; genotoxicity; safety assessment of inhalant drugs; immunotoxicology in pharmaceutical  Read more...


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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 Read more...

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