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[null,"1.","Record Nr.",null,"UNINA9910132349003321"]
[null,null,"Autore",null,"Kay R (Richard), <1949->"]
[null,null,"Titolo",null,"Statistical thinking for non-statisticians in drug regulation / / Richard Kay"]
[null,null,"Pubbl/distr/stampa",null,"Chichester, England : , : Wiley Blackwell, , 2015"]
[{"$nulls":4},"©2015"]
[null,null,"ISBN",null,"1-118-47097-4"]
[{"$nulls":4},"1-118-47099-0"]
[{"$nulls":4},"1-118-47096-6"]
[null,null,"Edizione",null,"[Second edition.]"]
[null,null,"Descrizione fisica",null,"1 online resource (370 p.)"]
[null,null,"Disciplina",null,"615.5/80724"]
[null,null,"Soggetti",null,"Drugs - Testing"]
[{"$nulls":4},"Drugs - Design"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Description based upon print version of record."]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"Basic ideas in clinical trial design -- Sampling and inferential statistics -- Confidence intervals and p-values -- Tests for simple treatment comparisons -- Adjusting the analysis -- Regression and analysis of covariance -- Intention-to-treat and analysis sets -- Power and sample size -- Statistical significance and clinical importance -- Multiple testing -- Non-parametric and related methods -- Equivalence and non-inferiority -- The analysis of survival data -- Interim analysis and data monitoring committees -- Bayesian statistics -- Adaptive designs -- Observational studies -- Meta-analysis -- Methods for the safety analysis and safety monitoring -- Diagnosis -- The role of statistics and statisticians."]
[null,null,null,"Sommario/riassunto","Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability"]
[null,"2.","Record Nr.",null,"UNINA9910813044303321"]
[null,null,"Autore",null,"Mihajlovic-Madzarevic Vera"]
[null,null,"Titolo",null,"Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections / / Vera Mihajlovic-Madzarevic"]
[null,null,"Pubbl/distr/stampa",null,"Hoboken, N.J., : John Wiley, 2010"]
[null,null,"ISBN",null,"9786613024848"]
[{"$nulls":4},"9780470920886"]
[{"$nulls":4},"0470920882"]
[{"$nulls":4},"9781283024846"]
[{"$nulls":4},"1283024845"]
[{"$nulls":4},"9780470572757"]
[{"$nulls":4},"0470572752"]
[{"$nulls":4},"9780470572740"]
[{"$nulls":4},"0470572744"]
[null,null,"Edizione",null,"[1st ed.]"]
[null,null,"Descrizione fisica",null,"1 online resource (270 p.)"]
[null,null,"Disciplina",null,"615.5/80724"]
[null,null,"Soggetti",null,"Drugs - Testing - Auditing"]
[{"$nulls":4},"Medical audit"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Description based upon print version of record."]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"CLINICAL TRIALSAUDIT PREPARATION; CONTENTS; PREFACE; INTRODUCTION; Background History on Clinical Research Standards; GLOSSARY; CHAPTER 1 GOOD CLINICAL PRACTICE AND THERAPEUTIC PRODUCT DEVELOPMENT; 1.1 Good Clinical Practice in Clinical Research; 1.1.1 Definition; 1.1.2 GCP Compliance; 1.1.3 GCP Objectives; 1.1.4 Principles of ICH GCP; Clinical Trial Conduct; Risk Assessment; Subject's Rights and Safety; Background Information; Clinical Trial Protocol; Ethics Review and Approval; Medical Care of Trial Subject; Qualifications of Clinical Trial Personnel; Informed Consent Process"]
[{"$nulls":4},"Data ManagementPatient Confidentiality; Investigational Product Manufacturing, Handling, and Storage; Quality Assurance; 1.1.5 GCP Applicability; 1.2 Role of the Sponsor of a Clinical Investigation; 1.2.1 GCP: Responsibilities of a Sponsor of a Clinical Trial; 1.2.2 Essential Documents for the Clinical Trial; Retention of the Essential Documents for the Clinical Trial; Archiving of the Essential Documents for the "]
[{"$nulls":4},"Clinical Trial After Discontinuation of Development; Notification; Transfer of Data Ownership; Records Retention; 1.2.3 Investigator Selection; Investigator's Qualifications"]
[{"$nulls":4},"Resources at the Investigator's SiteProtocol and Investigator's Brochure; Agreement with the Investigator/Institution; 1.2.4 Allocation of Responsibilities; 1.2.5 Compensation to Subjects and Investigators; Compensation to Subjects for Trial-Related Injuries; Other types of Compensation to Trial Subjects; 1.2.6 Financing; 1.2.7 Notification/Submission to Regulatory Authorities; 1.2.8 Confirmation of Review by IRB/IEC; 1.2.9 Information on Investigational Products; 1.2.10 Manufacturing, Packaging, Labelling, and Coding Investigational Products"]
[{"$nulls":4},"Characterization, Manufacturing, and Labeling of the Investigational ProductStorage Conditions; Packaging of the Investigational Product; Coding and Decoding of the Investigational Product; Investigational Product Changes and Bioequivalence Studies; 1.2.11 Supplying and Handling Investigational Products; Supply; Investigational Product Records; 1.2.12 Record Access; Verification of Patient Consent to Record Access; 1.2.13 Safety Information; Safety Issues; Communication of Safety Issues; 1.2.14 Adverse Drug Reaction Reporting; Serious Unexpected Adverse Drug Reactions"]
[{"$nulls":4},"SAE Reporting ComplianceSafety Updates and Periodic Reports; 1.2.15 Monitoring; Purposes; Selection and Qualifications of Monitors; Monitoring Strategies; Monitor's Responsibilities; Monitoring Procedures; Monitoring Report; 1.2.16 Audit; Selection and Qualifications of Auditors; Auditing Procedures; Site Selection Criteria for Inspection; Reporting of Findings; Audit Certificate; 1.2.17 Noncompliance; 1.2.18 Premature Termination or Suspension of a Trial; 1.2.19 Clinical Trial/Study Reports; 1.2.20 Multicenter Trials"]
[{"$nulls":4},"1.3 Role of the Institutional Review Board/Independent Ethics Committee (IRB/IEC)"]
[null,null,null,"Sommario/riassunto","A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investig"]
[null,"3.","Record Nr.",null,"UNINA9910866587403321"]
[null,null,"Titolo",null,"Christian Temporalities : Living Between the Already Fulfilled and the Not Yet Completed / / edited by Anna-Karina Hermkens, Simon Coleman, Matt Tomlinson"]
[null,null,"Pubbl/distr/stampa",null,"Cham : , : Springer Nature Switzerland : , : Imprint : Palgrave Macmillan, , 2024"]
[null,null,"ISBN",null,"9783031596834"]
[{"$nulls":4},"9783031596827"]
[null,null,"Edizione",null,"[1st ed. 2024.]"]
[null,null,"Descrizione fisica",null,"1 online resource (244 pages)"]
[null,null,"Collana",null,"Contemporary Anthropology of Religion, , 2946-3483"]
[null,null,"Disciplina",null,"306.6"]
[null,null,"Soggetti",null,"Anthropology of religion"]
[{"$nulls":4},"Philosophical anthropology"]
[{"$nulls":4},"Anthropology"]
[{"$nulls":4},"Ethnology"]
[{"$nulls":4},"Christianity"]
[{"$nulls":4},"Religion and sociology"]
[{"$nulls":4},"Anthropology of Religion"]
[{"$nulls":4},"Anthropological Theory"]
[{"$nulls":4},"Sociocultural Anthropology"]
[{"$nulls":4},"Sociology of Religion"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"Introduction: Living between the Already Fulfilled and the Not Yet Completed - Simon Coleman, Anna-Karina Hermkens, and Matt Tomlinson -- 2. When Historiopraxy Becomes Heritage - Simon Coleman -- 3. Competing Temporalities in a Fijian Pentecostal Church - Karen J. Brison -- 4. The Labour of History: Kerewo Christianity, Frustrated Modernity, and Historical Consciousness - Dario Di Rosa -- 5. Divine Control Read Backwards: How Zimbabwe’s New Calvinists Narrate God’s Plans - Leanne Williams Green -- 6. Sacred Drama and Temporal Tapestries: Invoking the Divine by Performing the Past in Contemplative Christianity - Paula Pryce -- 7. Fátima and the Referendum: Pilgrimage as Temporal Work in Bougainville Politics - Anna-Karina Hermkens -- 8. The Trouble with Christian Time: Thinking in Jewish - Joyce Dalsheim -- 9. Asmat Horizons of the Past - Jaap "]
[{"$nulls":4},"Timmer -- 10. Epilogue: Crafting Time - David Morgan."]
[null,null,null,"Sommario/riassunto","This volume explores how different forms of Christianity shape people's visions of pasts and futures, and how the transcendent is brought into human time. Beyond conventional discussions around breaks with the past in Christian conversion and future ruptures announced in prophecy, the volume reveals previously unexplored ways in which Christians work with concepts of time and its articulation with divinity, subjectivity, agency, and personal, social, and political change. By developing Coleman’s argument about “historiopraxy” in novel directions, contributors provide new understandings of religious temporalities and the ritual articulation of immanence and transcendence. While building upon previous scholarly work in the anthropology of Christianity, this volume pushes the debate further and provides original insights into how religion is mobilised to shape and transform people's pasts, presents and futures. Anna-Karina Hermkens is a senior lecturer and researcher in the School of Social Sciences at Macquarie University, Sydney, Australia. She has a background in Gender Studies, Religious Studies, and Cultural Anthropology. Her research focuses on the various interplays between gender, material culture, religion, and violence in Indonesia, Solomon Islands and Papua New Guinea, with particular attention to the power of Marian devotion in times of conflict and violence. Simon Coleman is Chancellor Jackman Professor at the Department for the Study of Religion, University of Toronto, Canada. His research focuses on the globalization of Pentecostalism, contemporary manifestations of pilgrimage, and Christian influences on urban infrastructures. Matt Tomlinson is Professor of Anthropology and Director of the School of Culture, History and Language in the College of Asia and the Pacific at the Australian National University. His research focuses on relationships between language, politics, and religious ritual in the Pacific Islands and Australia."]