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Textbook of Pharmacoepidemiology.

By: Contributor(s): Material type: TextPublisher: Newark : John Wiley & Sons, Incorporated, 2013Copyright date: ©2013Edition: 2nd edDescription: 1 online resource (476 pages)Content type:
  • text
Media type:
  • computer
Carrier type:
  • online resource
ISBN:
  • 9781118344859
Subject(s): Genre/Form: DDC classification:
  • 615.7042
Online resources:
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 -- Discussion -- Conclusion -- 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 reading -- 5 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 -- Limitations -- Particular 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 Reading -- 11 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 -- Currently available solutions -- The future -- Key points -- Further reading -- 13 Assessing Causality of Case Reports of Suspected Adverse Events -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Historical perspectives: development of concepts -- Uses of causality assessment -- Methodological problems to be addressed by pharmacoepidemiologic research -- Current tools -- Unstructured clinical judgment/global introspection -- Algorithm/criterial method with verbal judgments.
Algorithms requiring scoring of individual judgments -- Probabilistic methods -- Comparison among the different methods -- The future -- Key points -- Further reading -- 14 Molecular Pharmacoepidemiology -- Introduction -- Definitions and concepts -- The interface of pharmacogenetics and pharmacogenomics with molecular pharmacoepidemiology -- Clinical problems to be addressed by pharmacoepidemiologic research -- Three ways that genes can affect drug response -- The progression and application of molecular pharmacoepidemiologic research -- Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- The future -- Key points -- Further reading -- 15 Bioethical Issues in Pharmacoepidemiologic Research -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- Conclusion -- Key points -- Further reading -- 16 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodological problems to be solved by pharmacoepidemiologic research -- Currently available solutions -- The future -- Key points -- Further reading -- 17 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals -- Clinical problems to be addressed by pharmacoeconomic research -- Economic evaluation and the drug development process -- Methodological problems to be addressed by pharmacoeconomic research -- Methodological issues in the pharmacoeconomic assessment of therapies -- The future -- Key points -- Further Reading -- 18 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research.
Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- The future -- Key points -- Further reading -- 19 The Use of Meta-analysis in Pharmacoepidemiology -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- Currently available solutions -- The future -- Key points -- Further reading -- 20 Studies of Medication Adherence -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodologic problems to be solved by pharmacoepidemiologic research -- Currently available solutions -- Future directions -- Key points -- Further Reading -- 21 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- Conclusion -- Key points -- Further reading -- Part IV: Special Applications -- 22 Special Applications of Pharmacoepidemiology -- Studies of drug utilization -- Evaluating and improving physician prescribing -- Special methodological issues in pharmacoepidemiologic studies of vaccine safety -- Key points for special methodological issues in pharmacoepidemiologic studies of vaccine study -- Epidemiologic studies of implantable medical devices -- Studies of drug-induced birth defects -- Risk management -- The use of pharmacoepidemiology to study medication errors -- FDA's Sentinel Initiative: enhancing safety surveillance -- Comparative effectiveness research -- Further reading -- 23 The Future of Pharmacoepidemiology -- The view from academia -- The view from industry -- The view from regulatory agencies -- The view from the law.
Conclusion -- Key points -- Further Reading -- Appendix A-Sample Size Tables -- Appendix B-Glossary -- Index.
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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 -- Discussion -- Conclusion -- 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 reading -- 5 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 -- Limitations -- Particular 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 Reading -- 11 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 -- Currently available solutions -- The future -- Key points -- Further reading -- 13 Assessing Causality of Case Reports of Suspected Adverse Events -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Historical perspectives: development of concepts -- Uses of causality assessment -- Methodological problems to be addressed by pharmacoepidemiologic research -- Current tools -- Unstructured clinical judgment/global introspection -- Algorithm/criterial method with verbal judgments.

Algorithms requiring scoring of individual judgments -- Probabilistic methods -- Comparison among the different methods -- The future -- Key points -- Further reading -- 14 Molecular Pharmacoepidemiology -- Introduction -- Definitions and concepts -- The interface of pharmacogenetics and pharmacogenomics with molecular pharmacoepidemiology -- Clinical problems to be addressed by pharmacoepidemiologic research -- Three ways that genes can affect drug response -- The progression and application of molecular pharmacoepidemiologic research -- Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- The future -- Key points -- Further reading -- 15 Bioethical Issues in Pharmacoepidemiologic Research -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- Conclusion -- Key points -- Further reading -- 16 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodological problems to be solved by pharmacoepidemiologic research -- Currently available solutions -- The future -- Key points -- Further reading -- 17 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals -- Clinical problems to be addressed by pharmacoeconomic research -- Economic evaluation and the drug development process -- Methodological problems to be addressed by pharmacoeconomic research -- Methodological issues in the pharmacoeconomic assessment of therapies -- The future -- Key points -- Further Reading -- 18 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research.

Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- The future -- Key points -- Further reading -- 19 The Use of Meta-analysis in Pharmacoepidemiology -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- Currently available solutions -- The future -- Key points -- Further reading -- 20 Studies of Medication Adherence -- Introduction -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodologic problems to be solved by pharmacoepidemiologic research -- Currently available solutions -- Future directions -- Key points -- Further Reading -- 21 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies -- Clinical problems to be addressed by pharmacoepidemiologic research -- Methodological problems to be addressed by pharmacoepidemiologic research -- Currently available solutions -- Conclusion -- Key points -- Further reading -- Part IV: Special Applications -- 22 Special Applications of Pharmacoepidemiology -- Studies of drug utilization -- Evaluating and improving physician prescribing -- Special methodological issues in pharmacoepidemiologic studies of vaccine safety -- Key points for special methodological issues in pharmacoepidemiologic studies of vaccine study -- Epidemiologic studies of implantable medical devices -- Studies of drug-induced birth defects -- Risk management -- The use of pharmacoepidemiology to study medication errors -- FDA's Sentinel Initiative: enhancing safety surveillance -- Comparative effectiveness research -- Further reading -- 23 The Future of Pharmacoepidemiology -- The view from academia -- The view from industry -- The view from regulatory agencies -- The view from the law.

Conclusion -- Key points -- Further Reading -- Appendix A-Sample Size Tables -- Appendix B-Glossary -- Index.

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