Drug Safety Evaluation - Hardcover

Gad, Shayne Cox

Hardcover

ISBN 10: 0470253169 ISBN 13: 9780470253168

Publisher: Wiley, 2009

Synopsis

Drug Safety Evaluation

Second Edition

Shayne Cox Gad

The updated and expanded safety guide to all aspects of the drug development process

Drug Safety Evaluation, Second Edition 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.

This Second Edition has been extensively revised and expanded to respond to the many changes in regulatory requirements as well as pharmaceutical and technological developments. Drawing upon more than twenty years of experience, author Shayne Gad explains the scientific and philosophical bases for evaluating specific concerns (e.g., cardiovascular safety, immunogenicity, carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems.

Individual chapters address not only the general cases for safety evaluation of small and large molecules, but also all the significant major sub-cases: imaging agents, dermal and inhalation route drugs, vaccines, and gene-therapy products. Among the wide variety of topics covered are:

• Acute toxicity testing in pharmaceutical safety evaluation
• Genotoxicity
• Safety assessment of inhalant drugs
• Immunotoxicology in pharmaceutical development
• Large animal studies
• Evaluation of human tolerance and safety in clinical trials

More pertinent and practical than ever to the industry, Drug Safety Evaluation, Second Edition provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

About this title

From the Back Cover:

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.

Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including:
* Acute toxicity testing in pharmaceutical safety evaluation
* Genotoxicity
* Safety assessment of inhalant drugs
* Immunotoxicology in pharmaceutical development
* Large animal studies
* Evaluation of human tolerance and safety in clinical trials

Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

From the Inside Flap:

Drug Safety Evaluation

Second Edition

Shayne Cox Gad

About this edition

• Publisher: Wiley
• Publication date: 2009
• ISBN 10: 0470253169
• ISBN 13: 9780470253168
• Binding: Hardcover
• Edition number: 2
• Number of pages: 1200