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Post-authorization safety studies of medicinal products = the PASS book /

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Post-authorization safety studies of medicinal products/ edited by Ayad K. Ali, Abraham G. Hartzema.
Reminder of title:	the PASS book /
other author:	Ali, Ayad K.,
Published:	London, United Kingdom :Academic Press, an imprint of Elsevier, : 2018.,
Description:	1 online resource.
Notes:	Includes index.
Subject:	Drugs - Testing. -
Online resource:	https://www.sciencedirect.com/science/book/9780128092170
ISBN:	9780128092088 (electronic bk.)

Post-authorization safety studies of medicinal products = the PASS book /
Post-authorization safety studies of medicinal productsthe PASS book /[electronic resource] :edited by Ayad K. Ali, Abraham G. Hartzema. - London, United Kingdom :Academic Press, an imprint of Elsevier,2018. - 1 online resource.

Includes index.

Includes bibliographical references and index.

Intro; Title page; Table of Contents; Copyright; List of Contributors; Foreword; Chapter 1. Introduction; Risk Management and Benefit-Risk Evaluation; Transparency; About This Book; Chapter 2. Risk Management Process; Chapter 2.1. Risk Assessment; Chapter 2.2. Risk Minimization; Chapter 3. Data Sources for Post-Authorization Safety Studies; Chapter 3.1. Health Insurance Administrative Claims; Chapter 3.2. Electronic Medical Records; Chapter 3.3. Registries; Chapter 3.4. Big Data; Chapter 3.5. Social Media; Chapter 4. Study Designs for Post-Authorization Safety Studies

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.

ISBN: 9780128092088 (electronic bk.)Subjects--Topical Terms:

581825
Drugs
--Testing.Index Terms--Genre/Form:

554714
Electronic books.

LC Class. No.: RM301.9

Dewey Class. No.: 615.7/040287

National Library of Medicine Call No.: 2018 H-178

Post-authorization safety studies of medicinal products = the PASS book /
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245 0 0 $a Post-authorization safety studies of medicinal products $h [electronic resource] : $b the PASS book / $c edited by Ayad K. Ali, Abraham G. Hartzema.
260 $a London, United Kingdom : $b Academic Press, an imprint of Elsevier, $c 2018.
300 $a 1 online resource.
500 $a Includes index.
504 $a Includes bibliographical references and index.
505 0 $a Intro; Title page; Table of Contents; Copyright; List of Contributors; Foreword; Chapter 1. Introduction; Risk Management and Benefit-Risk Evaluation; Transparency; About This Book; Chapter 2. Risk Management Process; Chapter 2.1. Risk Assessment; Chapter 2.2. Risk Minimization; Chapter 3. Data Sources for Post-Authorization Safety Studies; Chapter 3.1. Health Insurance Administrative Claims; Chapter 3.2. Electronic Medical Records; Chapter 3.3. Registries; Chapter 3.4. Big Data; Chapter 3.5. Social Media; Chapter 4. Study Designs for Post-Authorization Safety Studies
505 8 $a Chapter 4.1. Drug Utilization and Prescription-Event Monitoring StudiesChapter 4.2. Self-Controlled Studies; Chapter 4.3. Cohort and Nested Case-Control Studies; Chapter 4.4. Enriched Studies; Chapter 4.5. Prospective Studies; Chapter 5. Analytical Approaches for Post-Authorization Safety Studies; Chapter 5.1. Exposure Propensity Scores; Chapter 5.2. Disease Risk Scores; Chapter 5.3. Instrumental Variables; Chapter 5.4. Data Analytic Platforms; Chapter 5.5. Proactive Safety Surveillance; Chapter 6. Benefit-Risk Evaluation; Chapter 6.1. Benefit-Risk Evaluation Frameworks
505 8 $a Chapter 6.2. Post-Authorization Effectiveness StudiesChapter 7. Post-Authorization Safety Studies for Specialty Products; Chapter 7.1. Post-Authorization Safety Studies for Biosimilars and Interchangeable Biologic Products; Chapter 7.2. Post-Authorization Safety Studies for Medical Devices and Combination Products; Chapter 7.3. Post-Authorization Safety Studies for Vaccines; Chapter 8. The European Union Post-Authorization Study Register; Disclaimer/Acknowledgments; Introduction; Index
520 $a 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.
650 0 $a Drugs $x Testing. $3 581825
650 0 $a Drug monitoring. $3 903499
650 1 2 $a Drug Evaluation. $3 557396
650 1 2 $a Product Surveillance, Postmarketing. $3 966134
650 2 2 $a Risk Management. $3 569483
650 7 $a MEDICAL $x Pharmacology. $2 bisacsh $3 791669
655 0 $a Electronic books. $2 local $3 554714
700 1 $a Ali, Ayad K., $e editor. $3 1344359
700 1 $a Hartzema, Abraham G., $e editor. $3 1344360
856 4 0 $u https://www.sciencedirect.com/science/book/9780128092170