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Pharmacovigilance
A Practical Approach
- 2nd Edition - November 20, 2024
- Editors: Thao Doan, Fabio Lievano, Linda Scarazzini, Charles Schubert, Barbara Hendrickson
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 1 1 8 8 1 - 4
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 1 9 3 1 - 6
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 1 9 3 0 - 9
Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance: A Practical Approach, Second Edition, provides a succinct, easy-to-d… Read more
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Request a sales quoteWritten by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance: A Practical Approach, Second Edition, provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. From cover to cover, this concise resource offers essential information for physicians and other health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
- Presents vital, easy-to-read, cutting-edge information on patient safety, the pharmacology regulatory landscape, and the current and future use of digital technologies
- Provides up-to-date coverage of hot topics in the field, including pharmacodynamic and safety precision medicine, immunogenicity, vaccine hesitancy and safety, genetic toxicology, and adverse events
- Contains new chapters on pre-clinical safety assessment, pharmacogenetics, first-in human trials, product aggregate safety assessment, data monitoring committees, and more
- Offers new and expanded coverage of pharmacovigilance in early pre-clinical drug development through post-marketing surveillance, as well as a blueprint for training future pharmacovigilance professionals
- Includes real-world case studies to ensure content is relevant and applicable to everyday practice
- Discusses a range of topics across disciplines and how they relate to pharmacovigilance, including behavioral science, patient perspectives, and risk communication
- An eBook version is included with purchase. The eBook allows you to access all of the text, figures and references, with the ability to search, customize your content, make notes and highlights, and have content read aloud. Additional digital ancillary content may publish up to 6 weeks following the publication date
Pharmacologists, clinician-scientists across disciplines, patient safety specialists
- Cover Image
- Title page
- Copyright
- Contributors
- Preface
- Acknowledgments
- Introduction
- Contents
- Section 1 The Regulatory Environment and the Pharmacovigilance Quality System
- Chapter 1 Does Regulation Drive Science or Does Science Drive Regulation?
- Introduction
- Important Events in Pharmacovigilance
- Important Pharmacovigilance Organizations
- National and Regional Regulatory Systems
- The World of Regulatory Science
- EMA Pharmacovigilance Risk Assessment Committee
- New Wave of Global PV Regulation—Are We Closer to Harmonization?
- Key Activities That Make Up a PV System
- The European Union Qualified Person for Pharmacovigilance
- The Rise of the National QPPV (N-QPPV)
- Conclusion
- References
- Section 2 Preclinical Safety Assessment
- Chapter 2 Absorption, Distribution, Metabolism and Excretion, Pharmacokinetics, and Safety Pharmacology
- Introduction
- Basic Principles of Absorption, Distribution, Metabolism, and Excretion
- Basic Pharmacokinetics Parameters
- Therapeutic Index and Safety Margins
- Safety Pharmacology Evaluation
- Conclusion
- References
- Chapter 3 Preclinical Safety Assessment: General and Genetic Toxicology
- Introduction
- Objectives of Nonclinical Safety Assessment
- Overview of General Toxicity Studies
- Genetic Toxicity and Carcinogenicity
- Other Toxicity Studies
- Conclusion
- References
- Chapter 4 Pharmacogenetics
- Introduction
- Background in Human Genetics
- Application of Genetics in Drug Discovery and Development
- Genetic Basis of Drug Response: Insights From Pharmacogenetics
- Pharmacogenetics of Marketed Compounds
- Direct-to-Consumer Pharmacogenetic Testing
- Conclusion
- List of Definitions
- References
- Section 3 First-In-Human Trials
- Chapter 5 Safety Planning for First-in-Human Trials
- Introduction
- The Process of Safety Planning for FIH Studies
- Reviewing the Relevant Data
- Safety Pharmacology Studies
- Toxicology Studies
- Drug Metabolism/Pharmacokinetic and Pharmacodynamic Studies
- Other Data
- Potential Risks and Safety Monitoring: Key Questions
- Do preclinical toxicology and toxicokinetic data fully support the dose range proposed and the estimated safety margin in humans?
- Does safety monitoring in the FIH study protocol adequately address preclinical safety issues identified?
- Does the proposed study have adequate subject and cohort stopping rules?
- Does the protocol have adequate gating of subject inclusion?
- Conclusion
- References
- Chapter 6 Pharmacokinetic and Pharmacodynamic Considerations in Safety Evaluation
- Introduction
- Pharmacokinetic and Pharmacodynamic parameters and markers of interest
- Differences in Pharmacokinetics between large and small molecules
- Intrinsic and Extrinsic factors that affect Pharmacokinetics
- Intrinsic factors
- Extrinsic factors
- Modeling approaches to characterize dose– and exposure–safety relationship
- Applications of Pharmacokinetics in “real-world” settings
- Communication of clinical pharmacology-related information
- Conclusions
- References
- Section 4 Safety Assessment in Clinical Trials
- Chapter 7 Safety Monitoring in Clinical Trials
- Introduction
- Safety Planning
- Data Collection and Evaluation
- Reporting and Communication of Safety Information
- Conclusion
- References
- Chapter 8 Introduction to Quantitative Methods and Visual Analytics in Drug Safety Data in Clinical Trials
- Introduction
- Role of Quantitative Methods and Visual Analytics in Drug Safety Assessment
- Enhancing Drug Safety Assessment via Quantitative and Visual Analytics
- Guidance on Using Quantitative Methods and Visual Analytics in Drug Safety
- A Structured Approach to the Statistical Analysis of Drug Safety Data
- Leveraging a Question-Based Approach
- Some Examples of Graphs in Drug Safety
- Adverse Events
- Bar Charts
- Tornado Plot
- Dot Plot
- Forest Plot
- Volcano Plot
- Clinical Laboratory Data
- Bar Charts
- Shift Plot
- Line Plot
- Box Plot
- Evaluation of Drug-Induced Serious Hepatotoxicity Plot
- Conclusion
- References
- Chapter 9 Product Aggregate Safety Assessment
- Introduction
- Evolution of Aggregate Safety Assessment Planning
- Importance of Safety Planning
- Processes Supported by Aggregate Safety Assessments
- Components of Safety Assessment Planning
- How an ASAP Supports IND Safety Reporting of Anticipated Events
- Conclusion
- References
- Chapter 10 Data Monitoring Committees
- Introduction
- The Evolution of DMC Over Time
- Types of DMCs
- Determining The Need for a DMC
- Operational Considerations for DMCs
- Regulatory Guidances on DMCs
- Statistical Support of DMCs
- Disclosure of DMC Assessments from Interim Looks at the Data
- Conclusion
- References
- Section 5 Signal and Risk Management
- Chapter 11 Methods of Signal Detection and Signal Management
- Introduction
- Data Sources and AE Reporting
- Signals
- Signal Detection
- Signal Validation
- Signal Assessment
- Determining Benefit–Risk
- Safety Governance in Pharmacovigilance
- Safety Governance Framework
- Safety Oversight Board
- Safety Management Teams19
- First-In-Human Review Committee20,21
- Internal Safety Advisory Groups
- Safety Governance Support
- Safety Governance Process
- Conclusion
- List of Definitions
- References
- Further Reading
- Chapter 12 Causality Assessment
- Introduction
- Definitions
- The Process of Determining Causality
- Systematic Approaches
- A Practical Approach to Causality Assessment: Elements to Consider
- Conclusion
- References
- Chapter 13 Examples of Adverse Drug Reactions: Drug-Induced Liver Injury, Renal, Skin, Immune-Mediated Events, and Major Adverse Cardiac Events
- Liver: Causality Assessment Indrug-Induced Liver Injury in Adults
- Renal
- Skin
- Immune-Mediated Reactions
- Cardiovascular
- Conclusion
- References
- Chapter 14 Internal Safety Advisory Groups
- Providing Consultations
- Preparing a Preread Data Package for Consult
- ISAG Meeting for the Consult
- Maintaining ISAG Metrics
- Standardizing Safety Data Collection, Analysis, and Presentation
- Example of the AbbVie Hepatic ISAG
- Enhancing ISAG Expertise and Knowledge Sharing
- References
- Chapter 15 Benefit–Risk Management
- Introduction
- Historical Background
- Structured Benefit–Risk Assessment
- Integrating the Life-Cycle Approach to Benefit–Risk Within a Biopharmaceutical Company
- Considerations for Key Benefits and Key Risks
- Graphic Visualization of Benefit–Risk Assessments
- Quantitative Benefit–Risk Assessments
- Role of the Patient in Benefit–Risk Assessment
- Role of the Patient in Developing Risk Minimization Tools
- Conclusion
- Appendix 1. Review of Risk Minimization
- References
- Section 6 Role of Epidemiology and Realworld Evidence
- Chapter 16 Role of Epidemiology and Pharmacoepidemiology in the Biopharmaceutical Industry
- Introduction
- Epidemiology Across the Drug Life Cycle
- Reviewing Published Evidence
- References
- Chapter 17 Real-World Pharmacoepidemiology Studies
- Introduction
- Broader Integration of RWE in Regulatory Decision-Making
- Real-World Data Sources
- Multi data Source Efforts
- Study Designs
- Decision-Grade Real-World Evidence
- Assessing and Addressing Potential Sources of Bias
- Transparency of Reporting
- Challenges and Opportunities
- References
- Section 7 Special Populations and Special Topics
- Chapter 18 Pharmacovigilance in Pregnancy
- Introduction
- Medication Use in Pregnant Females
- Stages of Embryo-Fetal Development
- Thalidomide and History of Regulations
- Developmental and Reproductive Toxicology
- Contraceptive Measures in Clinical Trials
- Seminal Fluid Exposure During Pregnancy
- Inclusion of Pregnant Females in Clinical Trials
- Inclusive Health Care in Special Populations in Clinical Trials
- Rationale for Postmarketing Safety Surveillance During Pregnancy
- Methods of Postmarketing Surveillance
- Pharmacovigilance by the Sponsor
- Pregnancy Registries
- Complementary Data Sources
- Conclusion
- References
- Chapter 19 Pharmacovigilance in Pediatrics
- Introduction
- Legislation for Pediatric Drug Development
- Unique Considerations in the Pediatric Population
- Unique Pharmacovigilance Challenges for Children
- Safety Data Collection to Improve Characterization of the Safety Profile of Medications Used in the Pediatric Population
- Conclusion
- References
- Chapter 20 Pharmacovigilance in the Elderly
- Introduction
- Conclusion
- References
- Chapter 21 Vaccine Pharmacovigilance
- Introduction
- Modern Vaccine History Related to Pharmacovigilance
- Monitoring Vaccine Safety During Prelicensure
- Postlicensure
- Benefit-Risk—the Provider and Consumer Levels
- The Future of Vaccine Safety
- References
- Chapter 22 Application of Human Factors and Health Literacy in Pharmacovigilance
- Introduction
- Human Factors
- Health Literacy
- Conclusion
- References
- Chapter 23 Medical Device Safety Oversight and Surveillance
- Introduction
- Medical Device Regulation in the United States
- Medical Device Development and Approval Pathways
- Tools and Methods of Device Risk Management and Safety Surveillance
- Design Control as a Safety Tool and Risk Mitigation
- The Birth of a (Hypothetical) Device
- Hazard Domains in Medical Devices
- Use Error
- Risk Quantification in the Device World: Three Ps
- Postmarket Surveillance of Medical Devices
- Other Sources of Complaints
- Reporting of Complaints
- Reportable Malfunctions
- Nonreportable Complaints
- Combination Products
- Combination = Sum of Parts
- Software as a Medical Device
- Conclusion
- Acknowledgment
- References
- Section 8 The Next Frontier
- Chapter 24 Information Technology in Pharmacovigilance: Current State and Future Directions
- Introduction to Pharmacovigilance Information Technologies
- Pharmacovigilance Data and Data Flow
- Pharmacovigilance Information Technologies for Adverse Event Report Capture
- Surveillance Process Technology
- Signal and Risk Assessment Technology
- Pharmacovigilance Information Technologies for Risk Minimization
- Additional Information Technologies for Patient Safety
- Conclusion
- Acknowledgment
- Appendix I: General PV Technology Framework
- Chapter 25 The Future of Pharmacovigilance
- Background
- Medical Assessment
- Cognitive and Behavioral Science
- Data Science
- Benefit-Risk: Bringing It All Together
- Conclusion
- References
- Index
- Language: English
- Edition: 2
- Published: November 20, 2024
- Imprint: Elsevier
- Paperback ISBN: 9780443118814
- eBook ISBN: 9780443119316
- eBook ISBN: 9780443119309
TD
Thao Doan
Thao Doan is Group Medical Director, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Department of Pharmacology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
Affiliations and expertise
Group Medical Director, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Department of Pharmacology, Northwestern University Feinberg School of Medicine, Chicago, IL, USAFL
Fabio Lievano
Fabio Lievano isVice President, Patient Safety, Scientific Collaborations, and New Business Advancement, Pharmacovigilance and Patient Safety, Epidemiology and, R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Affiliations and expertise
Vice President, Patient Safety, Scientific Collaborations, and New Business Advancement, Pharmacovigilance and Patient Safety, Epidemiology and, R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Northwestern University Feinberg School of Medicine, Chicago, IL, USALS
Linda Scarazzini
Linda Scarazzini is Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, United States.
Affiliations and expertise
Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, USACS
Charles Schubert
Charles Schubert is former Vice President, Oncology, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, United States.
Affiliations and expertise
Former Vice President, Oncology, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, USABH
Barbara Hendrickson
Barbara Hendrickson is Clinical Associate, Department of Pediatrics, University of Chicago, Chicago, IL, United States
Affiliations and expertise
Clinical Associate, Department of Pediatrics, University of Chicago, Chicago, IL, USA