LEADER 00863nam0-2200301 --450 001 9910308954603321 005 20190213130753.0 010 $a978-88-339-2570-7 020 $aIT$b2014-4803 100 $a20190213d2014----kmuy0itay5050 ba 101 0 $aita 102 $aIT 105 $a 001yy 200 1 $a<>vita segreta dei semi$fJonathan Silvertown$gtraduzione di Daria Restani 210 $aTorino$cBollati Boringhieri$d2014 215 $a243 p.$d19 cm 225 1 $aˆI ‰grandi pensatori$v92 610 0 $aSemi 676 $a581.467$v23$zITA 700 1$aSilvertown,$bJonathan W.$0749532 702 1$aRestani,$bDaria 801 0$aIT$bUNINA$gREICAT$2UNIMARC 901 $aBK 912 $a9910308954603321 952 $a60 581.467 SILJ 2014$b070/2019$fFAGBC 959 $aFAGBC 996 $aVita segreta dei semi$91542647 997 $aUNINA LEADER 12317nam 2200565 450 001 9910830156703321 005 20230104192222.0 010 $a1-119-70108-2 010 $a1-119-70110-4 010 $a1-119-70111-2 035 $a(CKB)4100000012037092 035 $a(MiAaPQ)EBC6735016 035 $a(Au-PeEL)EBL6735016 035 $a(OCoLC)1273976786 035 $a(EXLCZ)994100000012037092 100 $a20220626h20222022 uy 0 101 0 $aeng 135 $aurun#|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aTextbook of pharmacoepidemiology /$fedited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy 205 $aThird edition. 210 1$aHoboken, New Jersey :$cWiley Blackwell,$d[2022] 210 4$d©2022 215 $a1 online resource (557 pages) 311 $a1-119-70107-4 320 $aIncludes bibliographical references and index. 327 $aPreface -- 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. 327 $aBasics 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. 327 $aAssessing 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. 327 $aKey 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. 327 $aComparative 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. 327 $aChapter 14 Assessing Causality from Case Reports. 330 $a"It was a remarkable 32 years ago that the first edition of Strom's Pharmacoepidemiology was published. The preface to that book stated that pharmacoepidemiology was a new field with a new generation of pharmacoepidemiologists arising to join the field's few pioneers. Over the ensuing 32 years, the field indeed has grown and no longer deserves to be called "new." Many of those "new generation" scientists (including two of the editors of this book) are now "middle-aged" pharmacoepidemiologists. Despite its relatively brief academic life, a short history of pharmacoepidemiology and review of its current state will set the stage for the purpose of this textbook. Pharmacoepidemiology originally arose from the union of the fields of clinical pharmacology and epidemiology. Pharmacoepidemiology studies the use of and the effects of medical products in large numbers of people and applies the methods of epidemiology to the content area of clinical pharmacology. This field represents the science underlying postmarketing medical product surveillance, studies of the effects of medical products (i.e., drugs, biologicals, devices) performed after a product has been approved for use. In recent years, pharmacoepidemiology has expanded to include many other types of studies, as well"--$cProvided by publisher. 606 $aPharmacoepidemiology$vTextbooks 608 $aTextbooks.$2lcgft 615 0$aPharmacoepidemiology 676 $a615.7042 702 $aStrom$b Brian L. 702 $aKimmel$b Stephen E. 702 $aHennessy$b Sean 702 $aSedrakyan$b Art$pWeill Cornell Medical College. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910830156703321 996 $aTextbook of pharmacoepidemiology$94079500 997 $aUNINA