Post-Authorization Safety Studies of Medicinal Products - 1st Edition - ISBN: 9780128092170

Post-Authorization Safety Studies of Medicinal Products

1st Edition

The PASS Book

Editors: Ayad Ali Abraham Hartzema
Hardcover ISBN: 9780128092170
Imprint: Academic Press
Published Date: 1st June 2018
Page Count: 512
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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.

Key Features

  • Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settings
  • Presents various types of post-authorization safety studies
  • Offers solutions to the common challenges in the design and conduct of these studies
  • Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues


Pharmaceutical scientists in industry and contract research organizations and specifically, pharmacovigilance scientists, pharmacoepidemiologists, safety surveillance scientists, drug safety physicians and regulatory scientists; regulatory officials and professors and students in these areas and in outcomes research programs

Table of Contents

1. History and Regulatory Aspects of PASS


1.1: Development of Post-Authorization Safety Requirements

1.2: Role of PASS in Establishing Early Drug Safety Profiles

2. Risk Management Process


2.1: Risk Assessment

2.2: Risk Minimization

3. Pharmacovigilance


3.1: Signal Detection

3.2: Signal Clarification

3.3: Signal Evaluation

3.4: Disproportionality Analysis Methods

4. Signal Management


4.1: Interventional PASS

4.2: Non-Interventional PASS

5. Data Sources for PASS


5.1: Spontaneous Reporting Systems

5.2: Health Insurance Administrative Claims

5.3: Electronic Medical Records

5.4: Registries

5.5: Big Data

5.6: Social Media and Mobile Medical Applications

5.7: Publicly Available Cross-Sectional Data

6. Study Designs for PASS


6.1: Disproportionality Analysis and Proactive Safety Surveillance

6.2: Drug Utilization and Cohort Event Monitoring Studies

6.3: Cohort Event Monitoring Studies

6.4: Retrospectice Study Designs

6.4.1: Self-controlled Designs

6.4.2: Cohort Designs

6.5: Prospective Study Designs

6.6: Enriched Study Designs

7. Analytical Approaches for Bias Control in PASS


7.1: Exposure Propensity Scores

7.2: Disease Risk Scores

7.3: Instrumental Variables

7.4: Causal Inference

7.5: Data Analytic Platforms

7.6: Multi-Category Exposure Comparisons

8. Proactive Safety Surveillance


8.1: Proactive Safety Surveillance Programs

8.2: Proactive Safety Surveillance Methods

9. Benefit-Risk Evaluation


9.1: Benefit-Risk Evaluation Frameworks

9.2: Post-Authorization Effectiveness Studies

10. PASS for Biologics and Devices


10.1: PASS for Biosimilars and Interchangeable Biologic Products

10.2: PASS for Medical Devices and Combination Products

10.3: PASS for Vaccines

11. Transparency


11.1: EU PAS Register


11.3: CPRD Protocol Summaries

11.4: Pharmaceutical and Biopharmaceutical Companies

12. Resources

13. Abbreviations and Notations

14. Glossary


No. of pages:
© Academic Press 2018
Academic Press
Hardcover ISBN:

About the Editor

Ayad Ali

Dr. Ali is a senior pharmacoepidemiologist at Eli Lilly and Company and affiliate faculty at the College of Pharmacy, University of Florida and guest lecturer at the School of Public Health, Indiana University Purdue University and the University of Indianapolis. He is a Fulbright Scholar and has received many awards from professional and educational organizations, including complimentary memberships, travelships, and research and publication grants. He presented many of his research in pharmacovigilance and drug safety in national and international venues, and published in peer-reviewed journals. Additionally, he received memberships by election to the American College of Epidemiology and Sigma Xi the Scientific Research Society. He is a pharmacist by training and combines extensive experience in pharmacy practice in community, industrial, and academic settings, especially in pharmacoepidemiologic research and pharmacovigilance applications.

Affiliations and Expertise

Senior Pharmacoepidemiologist, Global Patient Safety, Eli Lilly and Company, IN, USA

Abraham Hartzema

Dr. Hartzema is an eminent scholar and professor at College of Pharmacy, University of Florida, he served as the academic advisor to Dr. Ali and has extensive experience in pharmacoepidemiology and drug risk management. He is the editor of several books in the area of pharmacoepidemiology, and published numerous research and expert opinion articles in peer-reviewed journals. He also served as the lead scientist for the active surveillance sentinel initiative by the Food and Drug Administration. He also appears in several editions of Who’s Who volumes.

Affiliations and Expertise

Professor and Eminent Scholar, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA

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