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 pharmacoepidemiology2883915UNINA05510nam 2201417Ia 450 991077892850332120230126202728.01-283-45702-497866134570281-4008-4235-210.1515/9781400842353(CKB)2550000000084273(EBL)859031(OCoLC)775872992(SSID)ssj0000612439(PQKBManifestationID)11363183(PQKBTitleCode)TC0000612439(PQKBWorkID)10571178(PQKB)11432087(MiAaPQ)EBC859031(StDuBDS)EDZ0000406917(MdBmJHUP)muse37195(DE-B1597)447200(OCoLC)1054882064(OCoLC)979582930(DE-B1597)9781400842353(Au-PeEL)EBL859031(CaPaEBR)ebr10533605(CaONFJC)MIL345702(EXLCZ)99255000000008427320110908d2012 uy 0engur|n|---|||||txtccrOn sacrifice[electronic resource] /Moshe HalbertalCourse BookPrinceton Princeton University Pressc20121 online resource (147 p.)Description based upon print version of record.0-691-16330-8 0-691-15285-3 Includes bibliographical references and index. Frontmatter -- Contents -- Acknowledgments -- Introduction -- Part I. Sacrificing to -- Part II. Sacrificing for -- Conclusion -- Notes -- IndexThe idea and practice of sacrifice play a profound role in religion, ethics, and politics. In this brief book, philosopher Moshe Halbertal explores the meaning and implications of sacrifice, developing a theory of sacrifice as an offering and examining the relationship between sacrifice, ritual, violence, and love. On Sacrifice also looks at the place of self-sacrifice within ethical life and at the complex role of sacrifice as both a noble and destructive political ideal. In the religious domain, Halbertal argues, sacrifice is an offering, a gift given in the context of a hierarchical relationship. As such it is vulnerable to rejection, a trauma at the root of both ritual and violence. An offering is also an ambiguous gesture torn between a genuine expression of gratitude and love and an instrument of exchange, a tension that haunts the practice of sacrifice. In the moral and political domains, sacrifice is tied to the idea of self-transcendence, in which an individual sacrifices his or her self-interest for the sake of higher values and commitments. While self-sacrifice has great potential moral value, it can also be used to justify the most brutal acts. Halbertal attempts to unravel the relationship between self-sacrifice and violence, arguing that misguided self-sacrifice is far more problematic than exaggerated self-love. In his exploration of the positive and negative dimensions of self-sacrifice, Halbertal also addresses the role of past sacrifice in obligating future generations and in creating a bond for political associations, and considers the function of the modern state as a sacrificial community.SacrificeSelf-sacrificeChristianity.God.Jewish life.Judaism.Paul Kahn.Western religious life.agent-relative actions.attentiveness.categorical imperative.charity.civilians.competition.cooperation.dependency.ethical life.ethics.evolutionary biology.exchange.general will.golden rule.heroic sacrifices.humans.individuals.instrumental relationship.laws of war.love.loyalty.martyr.modern state.moral sphere.original position.other.past sacrifice.political bond.political life.political order.political violence.politics.prayer.psychoanalysis.religion.religious life.reliigous communities.retroactive desecration.ritual.sacrifice.sacrificial community.sacrificial system.sacrificing for.self-interest.self-sacrifice.self-transcendence.self.social contract.soldiers.sovereign.state.suffering.temple worship.utilitarianism.violence.war.Sacrifice.Self-sacrifice.203/.4Halbertal Moshe764566MiAaPQMiAaPQMiAaPQBOOK9910778928503321On sacrifice3737227UNINA