Textbook of Pharmacoepidemiology.

Textbook of Pharmacoepidemiology, Second Edition, provides an introduction to pharmacoepidemiology and the methodologies, data sources and applications used in clinical practice, the pharmaceutical industry and regulatory agencies. This second edition includes new and updated learning features, case...

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Bibliographic Details
Main Author: Strom, Brian L.
Other Authors: Kimmel, Stephen E., Hennessy, Sean
Format: eBook
Language:English
Published: Hoboken : Wiley, 2013.
Edition:2nd ed.
Subjects:
Online Access:Click for online access
Table of Contents:
  • Textbook of Pharmacoepidemiology; Contents; Contributors; Preface; Acknowledgements; Part I: Introduction to Pharmacoepidemiology; 1 What is Pharmacoepidemiology?; Introduction; Definition of pharmacoepidemiology; Historical background; The current drug approval process; Potential contributions of pharmacoepidemiology; Key points; Further reading; 2 Study Designs Available for Pharmacoepidemiologic Studies; Overview of the scientific method; Types of errors that one can make in performing a study; Criteria for the causal nature of an association; Epidemiologic study designs; Case reports.
  • DiscussionConclusion; Key points; Further reading; 3 Sample Size Considerations for Pharmacoepidemiologic Studies; Introduction; Sample size calculations for cohort studies; Sample size calculations for case-control studies; Sample size calculations for case series; Discussion; Key points; References and further readings; 4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies; Clinical pharmacology and pharmacoepidemiology; Basics of clinical pharmacology; Pharmacokinetics; Special populations; Pharmacodynamics; Pharmacogenomics; Conclusion; Key points.
  • Further reading5 When Should One Perform Pharmacoepidemiologic Studies?; Reasons to perform pharmacoepidemiologic studies; Safety versus risk; Risk tolerance; Conclusion; Key points; Further reading; 6 Views from Academia, Industry, Regulatory Agencies, and the Legal System; The view from academia; Summary points for the view from academia; The view from industry; The view from regulatory agencies; The view from the legal system; Further reading; Part II: Sources of Pharmacoepidemiology Data; 7 Postmarketing Spontaneous Pharmacovigilance Reporting Systems; Introduction; Description; Strengths.
  • LimitationsParticular applications; The future; Key points; Further reading; 8 Overview of Automated Databases in Pharmacoepidemiology; Introduction; Description; Strengths; Weaknesses; Particular applications; The future; Key points; Further reading; 9 Examples of Existing Automated Databases; US Health maintenance organizations/health plans; US government claims databases; Canadian provincial databases; Medical record databases; Pharmacy-based medical record linkage systems; Further reading; 10 Field Studies; Strengths; Weaknesses; Particular applications; Conclusions; Key points.
  • Further Reading11 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives; Introduction; Choosing among the available approaches to pharmacoepidemiologic studies; Examples; Conclusion; Key points; Further reading; Part III: Special Issues in PharmacoepidemiologyMethodology; 12 Validity of Pharmacoepidemiologic Drug and Diagnosis Data; Introduction; Clinical problems to be addressed by pharmacoepidemiologic research; Methodological problems to be solved by pharmacoepidemiologic research; Methodological problems in pharmacoepidemiologic research.