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Post-Authorization Safety Studies of Medicinal Products

The PASS Book

Genres: Pharmacology
Format: Hardback
Publisher: Elsevier Science Publishing Co Inc, San Diego, United States
Imprint: Academic Press Inc
Published: 19th Jun 2018
Dimensions: w 194mm h 243mm d 28mm
Weight: 940g
ISBN-10: 0128092173
ISBN-13: 9780128092170
Barcode No: 9780128092170
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Synopsis
Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety.

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