Drug Safety Evaluation / Edition 2

Drug Safety Evaluation / Edition 2

by Shayne Cox Gad
     
 

Government regulatory agencies must approve any drug before it can be sold. This new edition of Drug Safety Evaluation presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Addressing specific approaches to evaluating hazards, including problems and solutions, the book covers the scientific and philosophical

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Overview

Government regulatory agencies must approve any drug before it can be sold. This new edition of Drug Safety Evaluation presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Addressing specific approaches to evaluating hazards, including problems and solutions, the book covers the scientific and philosophical bases for evaluation of specific concerns to provide both understanding and guidance for approaching new problems. This all-inclusive guide is of paramount interest to pharmaceutical scientists, toxicologists, drug safety scientists, academic researchers, and grad-level students.

Product Details

ISBN-13:
9780470253168
Publisher:
Wiley
Publication date:
06/09/2009
Series:
Pharmaceutical Development Series, #7
Edition description:
New Edition
Pages:
1200
Product dimensions:
6.40(w) x 9.40(h) x 2.30(d)

Table of Contents

Preface
About the Author
Ch. 1Strategy and Phasing for Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals1
Ch. 2Regulation of Human Pharmaceutical Safety30
Ch. 3Information Sources: Building and Maintaining Data Files99
Ch. 4Screens in Safety and Hazard Assessment112
Ch. 5Acute Toxicity Testing in Drug Safety Evaluation130
Ch. 6Genotoxicity176
Ch. 7Subchronic and Chronic Toxicity Studies237
Ch. 8Developmental and Reproductive Toxicity Testing258
Ch. 9Carcinogenicity Studies297
Ch. 10Safety Assessment of Inhalant Drugs335
Ch. 11Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment367
Ch. 12Special Concerns for the Preclinical Evaluation of Biotechnology Products404
Ch. 13Formulations, Routes, and Dosage Designs442
Ch. 14Occupational Toxicology in the Pharmaceutical Industry505
Ch. 15Immunotoxicology in Pharmaceutical Development527
Ch. 16Large Animal Studies595
Ch. 17The Application of In Vitro Techniques in Drug Safety Assessment634
Ch. 18Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation691
Ch. 19Safety Pharmacology737
Ch. 20Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond764
Ch. 21Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses (ADRs)831
Ch. 22Statistics in Pharmaceutical Safety Assessment862
App. ASelected Regulatory and Toxicological Acronyms971
App. BDefinition of Terms and Lexicon of Clinical Observations in Nonclinical (Animal) Studies975
App. CNotable Regulatory Internet Addresses979
App. DGlossary of Terms Used in the Clinical Evaluation of Therapeutic Agents990
Index997

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