11080nam 2200553 450 991055506830332120220826171448.01-119-70108-21-119-70110-41-119-70111-2(CKB)4100000012037092(MiAaPQ)EBC6735016(Au-PeEL)EBL6735016(OCoLC)1273976786(EXLCZ)99410000001203709220220626d2022 uy 0engu|||||||||txtrdacontentcrdamediacrrdacarrierTextbook of pharmacoepidemiology /edited by Brian L. Strom, Stephen E. Kimmel, Sean HennessyThird edition.Hoboken, New Jersey :Wiley Blackwell,[2022]©20221 online resource (557 pages)1-119-70107-4 Includes bibliographical references and index.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.PharmacoepidemiologyTextbooksElectronic books.Pharmacoepidemiology615.7042Strom Brian L.Kimmel Stephen E.Hennessy SeanSedrakyan ArtWeill Cornell Medical College.MiAaPQMiAaPQMiAaPQBOOK9910555068303321Textbook of pharmacoepidemiology2883915UNINA01647nam 2200397Ka 450 991069188770332120021119112826.0(CKB)5470000002348523(OCoLC)51032904ocm51032904(OCoLC)995470000002348523(EXLCZ)99547000000234852320021119d2002 ua 0engtxtrdacontentcrdamediacrrdacarrierA closer look at drug and violence prevention efforts in American schools[electronic resource] report on the study of school violence and prevention /[prepared for U.S. Department of Education, contract no. EA96055001 ; prepared by David Cantor ... and others ; Westat, Inc. in affiliation with Gottfredson Associates, Inc.]Washington, DC :U.S. Dept. of Education, Planning and Evaluation Service,[2002]August 2002.Title from title screen.Closer look at drug and violence prevention efforts in American schools Drug abuseUnited StatesPreventionSchool violenceUnited StatesPreventionDrug abusePrevention.School violencePrevention.Cantor David803273United States.Department of Education.Planning and Evaluation Service.Gottfredson Associates.Westat, Inc.GPOGPOBOOK9910691887703321A closer look at drug and violence prevention efforts in American schools3433548UNINA01847nam2 22004093i 450 VIA001514320231121125923.08833900320883390061420021113d1985 ||||0itac50 baitaitz01i xxxe z01n˜10.1: œCiviltà in transizione. Il periodo fra le due guerreCarl Gustav JungTorinoP. Boringhieri1985IX, 457 p.25 cm.001CFI00214782001 Opere di C. G. Jung[edizione diretta da Luigi Aurigemma]10Zivilisation im Übergang.RAV0019506CFIV00450920153CiviltàSec. 20.Psicologia socialeFIRRMLC444568E150.195421Jung, Carl GustavCFIV004509070123547Jung, Karl GustavCFIV123487Jung, Carl GustavJung, Carl G.CFIV195912Jung, Carl GustavITIT-0120021113IT-RM028 IT-RM0289 IT-RM0263 IT-RM0313 IT-FR0084 IT-FR0017 Biblioteca Universitaria AlessandrinaRM028 Biblioteca Statale A. BaldiniRM0289 BIBLIOTECA MEDICA STATALERM0263 BIBLIOTECA CASANATENSERM0313 Biblioteca Del Monumento Nazionale Di MontecassinoFR0084 Biblioteca umanistica Giorgio ApreaFR0017 VIA0015143Biblioteca umanistica Giorgio Aprea 52CIS 3/237.10.1 52VM 0000399955 VM barcode:00010142. - Inventario:20176 MAGVMA 2004021920121204 01 04 05 07 25 52Zivilisation im Übergang20153UNICAS