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 o...
Saved in:
Main Authors: | |
---|---|
Published: |
|
Literature type: | Electronic eBook |
Language: | English |
Subjects: | |
Online Access: |
http://onlinelibrary.wiley.com/book/10.1002/0471462993 |
Summary: |
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. |
Carrier Form: | 1 online resource (ix, 1007 pages) : illustrations |
Bibliography: | Includes bibliographical references and index. |
ISBN: |
0471459291 9780471459293 0471407275 9780471407270 0471462993 9780471462996 |
Index Number: | RA1238 |
CLC: | R965.3 |
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 evalu |