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Pharmacoepidemiology / / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy
| Pharmacoepidemiology / / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy |
| Autore | Strom Brian L |
| Edizione | [Sixth edition.] |
| Pubbl/distr/stampa | Hoboken, New Jersey ; ; West Sussex, England : , : Wiley-Blackwell, , [2020] |
| Descrizione fisica | 1 online resource (1,211 pages) |
| Disciplina | 615.7042 |
| Soggetto topico | Pharmacoepidemiology |
| ISBN |
1119413435
1-119-41342-7 9781119413431 9781119413417 1-119-41337-0 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910555186203321 |
Strom Brian L
|
||
| Hoboken, New Jersey ; ; West Sussex, England : , : Wiley-Blackwell, , [2020] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmacoepidemiology / / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy
| Pharmacoepidemiology / / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy |
| Autore | Strom Brian L |
| Edizione | [Sixth edition.] |
| Pubbl/distr/stampa | Hoboken, New Jersey ; ; West Sussex, England : , : Wiley-Blackwell, , [2020] |
| Descrizione fisica | 1 online resource (1,211 pages) |
| Disciplina | 615.7042 |
| Soggetto topico | Pharmacoepidemiology |
| ISBN |
1-119-41342-7
1-119-41343-5 1-119-41337-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910830531503321 |
|
Strom Brian L
|
||
| Hoboken, New Jersey ; ; West Sussex, England : , : Wiley-Blackwell, , [2020] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Textbook of pharmacoepidemiology / / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy
| Textbook of pharmacoepidemiology / / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley Blackwell, , [2022] |
| Descrizione fisica | 1 online resource (557 pages) |
| Disciplina | 615.7042 |
| Soggetto topico | Pharmacoepidemiology |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-119-70108-2
1-119-70110-4 1-119-70111-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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. |
| Record Nr. | UNINA-9910555068303321 |
| Hoboken, New Jersey : , : Wiley Blackwell, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Textbook of pharmacoepidemiology / / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy
| Textbook of pharmacoepidemiology / / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley Blackwell, , [2022] |
| Descrizione fisica | 1 online resource (557 pages) |
| Disciplina | 615.7042 |
| Soggetto topico | Pharmacoepidemiology |
| Soggetto genere / forma | Textbooks. |
| ISBN |
1-119-70108-2
1-119-70110-4 1-119-70111-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Preface -- 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. |
| Record Nr. | UNINA-9910830156703321 |
| Hoboken, New Jersey : , : Wiley Blackwell, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||