Textbook of Pharmacoepidemiology (eBook, PDF)

Redaktion: Strom, Brian L.; Hennessy, Sean; Kimmel, Stephen E.

• Format: PDF

Produktbeschreibung

Pharmacoepidemiology originally arose from the union of the fields of clinical pharmacology and epidemiology. Pharmacoepidemiology studies the use of and the effects of medical products in large numbers of people and applies the methods of epidemiology to the content area of clinical pharmacology. This field represents the science underlying studies of the effects of medical products (such as drugs, biologicals, and devices) in real world use. Strom's Textbook of Pharmacoepidemiology meets the increasing need for people to be trained in the field. Designed to meet the need of students, this textbook offers an approach that focuses on the core of the discipline, providing a focused educational resource for students. The book is designed for students at all levels: upper-level undergraduates, graduate students, post-doctoral fellows, and others who are learning the field. Case examples feature in most chapters, and all chapters include key points and a list of further reading. Fully revised and updated throughout, Textbook of Pharmacoepidemiology, 3rd edition is a useful introduction and resource for students of pharmacoepidemiology, both those enrolled in formal classes and those learning in "the real world," who will respond to the challenges that they encounter.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 560
• Erscheinungstermin: 23. September 2021
• Englisch
• ISBN-13: 9781119701088
• Artikelnr.: 62751085

Autorenporträt

About the Editors Brian L. Strom is Chancellor, Rutgers Biomedical and Health Sciences, University Professor, and Executive Vice President for Health Affairs, Rutgers University, Newark, NJ, USA. Stephen E. Kimmel is Dean's Professor and Chair of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, USA. Sean Hennessy is Professor of Epidemiology and Director of the Center for Pharmacoepidemiology Research and Training, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.

Inhaltsangabe

Contributors xvii Preface xxi Acknowledgements xxv Part I Introduction to
Pharmacoepidemiology 1 1 What is Pharmacoepidemiology? 3 Brian L. Strom
Introduction 3 Definition of Pharmacoepidemiology 3 Historical Background 5
The Current Drug Approval Process 13 Potential Contributions of
Pharmacoepidemiology 15 Key Points 18 Further Reading 18 2 Study Designs
Available for Pharmacoepidemiologic Studies 20 Brian L. Strom Introduction
20 Overview of the Scientific Method 20 Types of Errors that one Can Make
in Performing a Study 22 Criteria for the Causal Nature of an Association
23 Epidemiologic Study Designs 26 Discussion 31 Conclusion 32 Key Points 32
Further Reading 33 3 Sample Size Considerations for Pharmacoepidemiologic
Studies 35 Brian L. Strom Introduction 35 Sample Size Calculations for
Cohort Studies 35 Sample Size Calculations for Case-Control Studies 40
Sample Size Calculations for Case Series 41 Discussion 43 Key Points 45
Further Reading 45 4 Basic Principles of Clinical Pharmacology Relevant to
Pharmacoepidemiologic Studies 47 Jeffrey S. Barrett Introduction 47
Clinical Pharmacology and Pharmacoepidemiology 48 Basics of Clinical
Pharmacology 48 Pharmacokinetics 49 Special Populations 52 Pharmacodynamics
56 Pharmacogenomics 59 Model-Informed Drug Development 59 Conclusion 60 Key
Points 60 Further Reading 61 5 When Should One Perform
Pharmacoepidemiologic Studies? 62 Brian L. Strom Introduction 62 Reasons to
Perform Pharmacoepidemiologic Studies 62 Safety Versus Risk 67 Risk
Tolerance 67 Conclusion 70 Key Points 70 Further Reading 71 6 Views from
Academia, Industry, Regulatory Agencies, and the Legal System 73 Joshua J.
Gagne, Jerry Avorn, Nicolle M. Gatto, Jingping Mo, Gerald J. Dal Pan, June
Raine, Shinobu Uzu, Aaron S. Kesselheim, and Kerstin N. Vokinger The View
from Academia 73 The View from Industry 81 The View from Regulatory
Agencies 90 The View from the Legal System 98 Further Reading 107 Part II
Sources of Pharmacoepidemiology Data 113 7 Postmarketing Spontaneous
Pharmacovigilance Reporting Systems 115 Gerald J. Dal Pan, Marie Lindquist,
and Kate Gelperin Introduction 115 Description 116 Strengths 128
Limitations 129 Particular Applications 131 The Future 132 Key Points 132
Further Reading 134 8 Overview of Electronic Databases in
Pharmacoepidemiology 136 Brian L. Strom Introduction 136 Description 137
Strengths 138 Weaknesses 139 Particular Applications 140 The Future 140 Key
Points 141 Further Reading 141 9 Encounter Databases 142 Tobias Gerhard,
Yola Moride, Anton Pottegård, and Nicole Pratt Introduction 142 Description
142 Strengths 161 Limitations 162 Particular Applications 163 The Future
166 Key Points 167 Further Reading 171 US Databases 172 European Databases
172 Canadian Databases 173 Asian Databases 173 10 Electronic Health Record
Databases 174 Daniel B. Horton, Harshvinder Bhullar, Francesca Cunningham,
Janet Sultana, and Gialuca Trifirò Introduction 174 Description 174
Strengths 184 Limitations 185 The Future 186 Summary Points for Electronic
Health Record Databases 187 Acknowledgment 187 Further Readings 189 11
Primary Data Collection for Pharmacoepidemiology 192 Priscilla Velentgas
Introduction 192 Methods of Primary Data Collection 195 Strengths 197
Limitations 197 Particular Applications 198 Conclusions 199 Key Points 199
Further Reading 201 12 How Should One Perform Pharmacoepidemiologic
Studies? Choosing Among the Available Alternatives 203 Brian L. Strom
Introduction 203 Choosing Among the Available Approaches to
Pharmacoepidemiologic Studies 203 Examples 215 Conclusion 216 Key Points
216 Further Reading 216 Part III Special Issues in Pharmacoepidemiology
Methodology 219 13 Validity of Drug and Diagnosis Data in
Pharmacoepidemiology 221 Mary Elizabeth Ritchey, Suzanne L. West, and
George Maldonado Introduction 221 Clinical Problems to be Addressed by
Pharmacoepidemiologic Research 221 Methodological Problems to be Solved by
Pharmacoepidemiologic Research 222 Currently Available Solutions 233 The
Future 242 Key Points 242 Further Reading 243 14 Assessing Causality from
Case Reports 246 Bernard Bégaud and Judith K. Jones Introduction 246
Clinical Problems to be Addressed by Pharmacoepidemiologic Research 246 The
Two Paradigms of Causality Assessment 246 When is Assessing Causation from
Cases Reports Useful? 247 Methodological Problems to be Addressed by
Pharmacoepidemiologic Research 248 Approaches for Assessing Causation from
Individual Cases 249 Calibration 253 Choosing the Appropriate Approach 253
The Future 254 Key Points 255 Further Reading 255 15 Molecular
Pharmacoepidemiology 257 Christine Y. Lu and Stephen E. Kimmel Introduction
257 Definitions and Concepts 258 The Interface of Pharmacogenetics and
Pharmacogenomics with Molecular Pharmacoepidemiology 259 Clinical Problems
to be Addressed by Pharmacoepidemiologic Research 260 The Progression and
Clinical Application of Molecular Pharmacoepidemiology 264 Methodological
Problems to be Addressed by Pharmacoepidemiologic Research 264 Currently
Available Solutions 269 The Future 271 Key Points 273 Further Reading 274
16 Bioethical Issues in Pharmacoepidemiologic Research 276 Laura E.
Bothwell, Annika Richterich, and Jeremy Greene Introduction 276 Clinical
Problems to be Addressed by Pharmacoepidemiologic Research 276 Methodologic
Problems to be Solved by Pharmacoepidemiologic Research 283 Currently
Available Solutions 286 The Future 289 Acknowledgement 291 Key Points 291
Further Reading 293 17 The Use of Randomized Controlled Trials for
Pharmacoepidemiology 294 Samuel M. Lesko, Allen A. Mitchell, and Robert F.
Reynolds Introduction 294 Clinical Problems to be Addressed by
Pharmacoepidemiologic Research 294 Methodological Problems to be Solved by
Pharmacoepidemiologic Research 296 Currently Available Solutions 298 Large
Simple Trials 298 Analysis 303 Primary Analysis 303 The Future 304 Key
Points 305 Further Reading 305 18 Pharmacoeconomics: Economic Evaluation of
Pharmaceuticals 307 Kevin A. Schulman Introduction 307 Clinical Problems to
be Addressed by Pharmacoeconomic Research 307 Methodological Problems to be
Addressed by Pharmacoeconomic Research 312 The Future 320 Acknowledgements
320 Key Points 320 Further Reading 320 19 Patient Engagement and Patient
Reported Outcomes 322 Esi M. Morgan and Adam C. Carle Introduction 322
Patient Reported Outcomes in Clinical Trials 323 Patient Reported Outcomes
in Routine Care 323 Patient Reported Outcomes as Motivation to Develop New
Therapeutic Strategies 325 Clinical Problems to be Addressed by
Pharmacoepidemiologic Research 326 Methodologic Problems to be Solved by
Pharmacoepidemiologic Research 328 Currently Available Solutions 328 The
Future 330 Key Points 331 Further Reading 331 20 The Use of Meta-analysis
in Pharmacoepidemiology 334 Brenda J. Crowe, Stephen J.W. Evans, H. Amy
Xia, and Jesse A. Berlin Introduction 334 Clinical Problems to be Addressed
by Pharmacoepidemiologic Research 335 Methodological Problems to be Solved
by Pharmacoepidemiologic Research 336 Currently Available Solutions 338 The
Future 350 Key Points 351 Further Reading 352 21 Studies of Medication
Adherence 355 Julie Lauffenburger, Trisha Acri, and Robert Gross
Introduction 355 Clinical Problems to be Addressed by Pharmacoepidemiologic
Research 356 Methodological Problems to be Addressed by
Pharmacoepidemiologic Research 357 Currently Available Solutions 357
Analysis Issues in Adherence 362 Use of Adherence Data in Clinical Trials
and Comparative Effectiveness Studies 362 The Future 365 Key Points 365
Further Reading 366 22 Advanced Approaches to Controlling Confounding in
Pharmacoepidemiologic Studies 368 Sebastian Schneeweiss and Samy Suissa
Introduction 368 Clinical Problems to be Addressed by Pharmacoepidemiologic
Research 368 Methodological Problems to be Addressed by
Pharmacoepidemiologic Research 368 Currently Available Solutions 370
Conclusion 382 Key Points 382 Further Reading 384 Part IV Special
Applications and the Future of Pharmacoepidemiology 387 23 Special
Applications of Pharmacoepidemiology 389 David Lee, Björn Wettermark,
Christine Y. Lu, Stephen B. Soumerai, Robert T. Chen, Sharon-Lise
T.Normand, Art Sedrakyan, Danica Marinac-Dabic, Daniel B. Horton, Sonia
Hernandez-Diaz, Tamar Lasky, Krista F. Huybrechts, Claudia Manzo, Emil
Cochino, Hanna M. Seidling, David W. Bates, Bennett Levitan, Rachael L.
DiSantostefano, and Scott Evans Studies of Drug Utilization 389
Introduction 389 Evaluating and Improving Prescribing 398 Special
Methodological Issues in Pharmacoepidemiologic Studies of Vaccine Safety
403 Epidemiologic Studies of Implantable Medical Devices 408 Research on
the Effects of Medications in Pregnancy and in Children 418 Risk Management
427 The Pharmacoepidemiology of Medication Errors 436 Benefit-Risk
Assessments of Medical Treatments 442 Further Reading 454 24 The Future of
Pharmacoepidemiology 464 Brian L. Strom, Stephen E. Kimmel, and Sean
Hennessy Introduction 464 The View from Academia 465 Scientific
Developments 465 The View from Industry 471 The View from Regulatory
Agencies 472 The View from the Law 473 Conclusion 473 Key Points 473
Further Reading 474 Appendix A -- Sample Size Tables 475 Appendix B --
Glossary 493 Index 505