Safety pharmacology in pharmaceutical development
Subtitle: approval and post marketing surveillance
By: Shayne C. Gad
Edition: 2nd ed.
Publisher: CRC Press/Taylor & Francis
Published: 2012
Place of publication: Boca Raton, FL
Language: eng
ISBN-13: 9781439845677
Subjects: Toxicity Tests; Postmarketing Product Surveillance; Drug Approval; Preclinical Drug Evaluation
Description: "This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs, from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years of direct experience, the author describes tricks and practical insights for making studies work and understanding why they don't. The second edition includes current regulations (US FDA and international especially Europe and Japan) and updated test methods, interpretation, and science"--Provided by publisher.
Notes: Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.

Includes bibliographical references and index.