Safety pharmacology in pharmaceutical development [electronic resource] : approval and post marketing surveillance / Shayne C. Gad
- 作者： Gad, Shayne C. 1948-
- 出版： Boca Raton, FL : CRC Press c2012
- 主題： Drugs--Toxicology. , Drugs--Safety measures. , Drug development--Safety measures , Drug Evaluation, Preclinical , Drug Approval , Product Surveillance, Postmarketing , Toxicity Tests
- 版本：2nd ed.
- ISBN： 9781439845684 (electronic bk.)
- URL：
電子書
- 一般註：Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004 Description based on print version record
- 書目註：Includes bibliographical references and index
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讀者標籤：
- 系統號： 005233883 | 機讀編目格式
館藏資訊
摘要註
"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
內容註
Safety pharmacology: background, history, issues and concerns -- Regulatory requirements: ICH, FDA, EMA, and Japan -- Principles of screening and study design -- Cardiovascular system -- Central nervous system -- Respiratory system -- Renal function -- Gastrointestinal system -- Immune system