Textbook of pharmacoepidemiology / / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy

• Pubblicazione: Hoboken, New Jersey : , : Wiley Blackwell, , [2022]; ©2022
• Edizione: Third edition.
• Descrizione fisica: 1 online resource (557 pages)
• Disciplina: 615.7042
• Soggetto topico: Pharmacoepidemiology
• Soggetto genere / forma: Electronic books.
• Persona (resp. second.): StromBrian L.; KimmelStephen E.; HennessySean; SedrakyanArt (Weill Cornell Medical College.)
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: Cover -- Title Page -- Copyright Page -- Contents -- List of Contributors -- Preface -- Acknowledgments -- Part I Introduction to Pharmacoepidemiology -- Chapter 1 What is Pharmacoepidemiology? -- Introduction -- Definition of Pharmacoepidemiology -- Pharmacoepidemiology Versus Clinical Pharmacology -- Pharmacoepidemiology Versus Epidemiology -- Historical Background -- Early Legislation -- Drug Crises and Resulting Regulatory Actions -- Legislative Actions Resulting from Drug Crises -- Intellectual Development of Pharmacoepidemiology Emerging from Drug Crises -- The Current Drug Approval Process -- Drug Approval in the US -- Drug Approval in Other Countries -- Potential Contributions of Pharmacoepidemiology -- Supplementary Information -- New Types of Information Not Available from Premarketing Studies -- General Contributions of Pharmacoepidemiology -- Key Points -- Further Reading -- Chapter 2 Study Designs Available for Pharmacoepidemiologic Studies -- Introduction -- 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 -- Case Series -- Analyses of Secular Trends -- Case-Control Studies -- Cohort Studies -- Analysis of Case-Control and Cohort Studies -- Randomized Clinical Trials -- Discussion -- Conclusion -- Key Points -- Further Reading -- Chapter 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 -- Further Reading -- Chapter 4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies -- Introduction -- Clinical Pharmacology and Pharmacoepidemiology. ; Basics of Clinical Pharmacology -- Pharmacokinetics -- Absorption -- Volume of Distribution -- Metabolism -- Elimination -- Special Populations -- Elderly -- Pediatrics -- Pregnancy -- Organ Impairment -- Drug Interactions -- Pharmacodynamics -- Overview -- Pharmacogenomics -- Model-Informed Drug Development -- Conclusion -- Key Points -- Further Reading -- Chapter 5 When Should One Perform Pharmacoepidemiologic Studies? -- Introduction -- Reasons to Perform Pharmacoepidemiologic Studies -- Regulatory -- Marketing -- Legal -- Clinical -- Safety Versus Risk -- Risk Tolerance -- Features of the Adverse Outcome -- Characteristics of the Exposure -- Perceptions of the Evaluator -- Conclusion -- Key Points -- Further Reading -- Chapter 6 Views from Academia, Industry, Regulatory Agencies, and the Legal System -- The View from Academia -- Introduction -- The Drug Approval Process -- Prescribing Practices -- Evaluation of Patients' Use of Drugs in the Health Care System -- Assessment of the Quality and Outcomes of Medication Use in Populations -- Policy Analysis -- Interventional Pharmacoepidemiology -- Economic Assessment of Medication-Related Issues -- The Academic Medical Center -- Consortia of Academic Medical Center Programs for Pharmacoepidemiologic Research -- The Future -- Summary Points for the View from Academia -- The View from Industry -- Introduction -- Regulatory and Industry Focus on Risk Management and Epidemiology -- Epidemiology in Drug Safety Evaluation -- Epidemiology in Evaluation of Risk Mitigation Interventions -- Conclusion -- Summary Points for the View from Industry -- The View from Regulatory Agencies -- Introduction -- Assessing the Need for Medicines -- Orphan Drugs -- Planning Drug Development Programs -- Pre-approval Review of Clinical Safety Data -- Planning for Post-approval Studies -- Monitoring Post-approval Safety. ; Assessing Actual Use Patterns of a Medicine -- Assessing Impact of Regulatory Actions -- Advancing the Science of Pharmacoepidemiology -- Conclusion -- Summary Points for the View from Regulatory Agencies -- The View from the Legal System -- Introduction -- Tort Law and Product Liability Lawsuits -- Pharmacoepidemiology and Contract Law -- Pharmacoepidemiology and Intellectual Property Law -- Conclusion -- Summary Points for the View from the Legal System -- Further Reading -- The View from Academia -- The View from Industry -- The View from Regulatory Agencies -- The View from the Legal System -- Contract-Related Issues in Pharmacoepidemiology -- Patent Law and Pharmacoepidemiology -- Part II Sources of Pharmacoepidemiology Data -- Chapter 7 Postmarketing Spontaneous Pharmacovigilance Reporting Systems -- Introduction -- Description -- Adverse Events and Adverse Drug Reactions -- Overview of Pharmacovigilance Reporting Systems -- The Concept of Spontaneous AE/ADR Reporting -- Report Characteristics -- Social Media -- National Pharmacovigilance Systems -- National and International Postmarketing Adverse Event Databases -- Detecting Signals from a Postmarketing Adverse Event Database -- Review of Individual Case Safety Reports -- Reporting Ratios -- Strengths -- Signal Detection -- Opportunity for the Public to Report AEs/ADRs -- Scope -- Limitations -- Quality of Reports -- Underreporting -- Non-uniform Temporal Trends in Reporting -- Particular Applications -- Case Series and Reporting Rates -- Data Mining Signals -- Signals from Developing Countries -- The Future -- Key Points -- Further Reading -- Chapter 8 Overview of Electronic Databases in Pharmacoepidemiology -- Introduction -- Description -- Claims and Other Administrative Databases -- Electronic Health Record Databases -- Strengths -- Weaknesses -- Particular Applications -- The Future. ; Key Points -- Further Reading -- Chapter 9 Encounter Databases -- Introduction -- Description -- Attributes of Encounter Databases -- Selected Encounter Databases -- Strengths -- Limitations -- Particular Applications -- Typical Activities Involved in Studies Using Encounter Databases -- Deciding Between Individual Encounter Databases -- The Future -- Key Points -- Further Reading -- US Databases -- European Databases -- Canadian Databases -- Asian Databases -- Chapter 10 Electronic Health Record Databases -- Introduction -- Description -- Overview of Health Care Systems and Populations -- Overview of Databases -- Data Collection and Structure -- Data Quality: Accuracy and Completeness -- Data Access for Researchers -- Strengths -- Population-Based Data, Sample Size, and Length of Follow-up -- Validity of Clinical Information -- Accuracy of Drug Information -- Ability to Access Original Health Records -- Linkage to External Patient-Level Data -- Limitations -- Incompleteness of Clinical Data -- Incompleteness of Drug Data -- The Future -- Summary Points for Electronic Health Record Databases -- Acknowledgment -- Further Readings -- Chapter 11 Primary Data Collection for Pharmacoepidemiology -- Introduction -- Research Questions that Require Primary Data -- Hybrid or Enriched Designs -- Methods of Primary Data Collection -- Site-Based Data Collection -- Clinician or Site-Reported Outcomes (ClinROs) -- Patient-Generated Data -- Registries as Means of Data Collection -- Biobanks/Specimen Banks -- Guidelines on the Quality of Data Collection -- Strengths -- Limitations -- Particular Applications -- Conclusions -- Key Points -- Further Reading -- Chapter 12 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives -- Introduction -- Choosing Among the Available Approaches to Pharmacoepidemiologic Studies. ; Comparative Characteristics of Pharmacoepidemiologic Data Resources -- Characteristics of Research Questions and their Impact on the Choice of Pharmacoepidemiologic Data Resources -- Examples -- Conclusion -- Key Points -- Further Reading -- Part III Special Issues in Pharmacoepidemiology Methodology -- Chapter 13 Validity of Drug and Diagnosis Data in Pharmacoepidemiology -- Introduction -- Clinical Problems to be Addressed by Pharmacoepidemiologic Research -- Methodological Problems to be Solved by Pharmacoepidemiologic Research -- Indices of Measurement Error Relevant to Pharmacoepidemiologic Research -- Quantitative Measurement of Validity -- Quantitative Measurement of Reliability -- Measurement Error in Pharmacoepidemiologic Research -- Adjusting Measures of Association for Measurement Error -- Self-Reported Drug Data from Ad hoc Survey Studies: Recall Accuracy -- The Influence of Medication Class -- The Influence of Questionnaire Design -- The Influence of Patient Population -- Self-Reported Diagnosis and Hospitalization Data from Ad hoc Studies: Recall Accuracy -- The Influences of Medical Condition Type -- The Influences of Timing of Diagnosis and Its Emotional Effects on the Patient -- The Influence of Patient Population -- The Influence of Questionnaire Design -- Currently Available Solutions -- Following Best Practices for Questionnaire Design -- Developing a De novo Questionnaire -- Conducting Validation Studies to Assess Self-Reported Data -- Considering the Influence of Comparator Selection on Validation Studies -- Validation of Pharmacoepidemiologic Drug and Diagnosis Data from Electronic Encounter Databases -- Special Considerations with Drug Data -- Special Considerations with Diagnosis and Hospitalization Data -- Special Considerations with Distributed Data Systems -- Best Practices -- The Future -- Key Points -- Further Reading. ; Chapter 14 Assessing Causality from Case Reports.
• Titolo autorizzato: Textbook of pharmacoepidemiology
• ISBN: 1-119-70108-2; 1-119-70110-4; 1-119-70111-2
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910555068303321
• Lo trovi qui: Univ. Federico II