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Analysis of data from randomized controlled trials : a practical guide / / Jos W. R. Twisk
Analysis of data from randomized controlled trials : a practical guide / / Jos W. R. Twisk
Autore Twisk Jos W. R. <1962->
Pubbl/distr/stampa Cham, Switzerland : , : Springer, , [2021]
Descrizione fisica 1 online resource (167 pages)
Disciplina 616.027
Soggetto topico Clinical trials
Assaigs clínics
Soggetto genere / forma Llibres electrònics
ISBN 3-030-81865-9
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNISA-996466413903316
Twisk Jos W. R. <1962->  
Cham, Switzerland : , : Springer, , [2021]
Materiale a stampa
Lo trovi qui: Univ. di Salerno
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Bayesian adaptive design for immunotherapy and targeted therapy / / by Haitao Pan, Ying Yuan
Bayesian adaptive design for immunotherapy and targeted therapy / / by Haitao Pan, Ying Yuan
Autore Pan Haitao
Edizione [First edition 2023.]
Pubbl/distr/stampa Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2023
Descrizione fisica 1 online resource (XI, 262 p. 58 illus., 50 illus. in color.) : illustrations
Disciplina 570.15195
Soggetto topico Biometry
Biostatistics
Clinical Trial Protocols as Topic
Adaptive Clinical Trials as Topic
Bayes Theorem
Immunoteràpia
Dianes farmacològiques
Assaigs clínics
Estadística matemàtica
Estadística bayesiana
Soggetto genere / forma Llibres electrònics
ISBN 981-19-8176-0
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Introduction to Adaptive Design and Delayed Outcomes -- Basics of Bayesian Statistics -- Phase I Dose-finding Design -- Phase II Design for Interim Monitoring -- Phase I-II Dose-finding Design -- Drug Combination Trial Design -- Conclusion.
Record Nr. UNINA-9910717420903321
Pan Haitao  
Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2023
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Behavioral clinical trials for chronic diseases : scientific foundations / / Lynda H. Powell, Kenneth E. Freedland, Peter G. Kaufmann
Behavioral clinical trials for chronic diseases : scientific foundations / / Lynda H. Powell, Kenneth E. Freedland, Peter G. Kaufmann
Autore Powell Lynda H.
Pubbl/distr/stampa Cham, Switzerland : , : Springer, , [2021]
Descrizione fisica 1 online resource (324 pages)
Disciplina 616.044
Soggetto topico Chronic diseases
Behavior therapy - Research
Chronic diseases - Treatment - Research
Malalties cròniques
Teràpia de la conducta
Investigació mèdica
Assaigs clínics
Soggetto genere / forma Llibres electrònics
ISBN 3-030-39330-5
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNINA-9910502589503321
Powell Lynda H.  
Cham, Switzerland : , : Springer, , [2021]
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Fundamentals of clinical trials / / by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
Fundamentals of clinical trials / / by Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
Autore Friedman Lawrence M
Edizione [5th ed. 2015.]
Pubbl/distr/stampa Cham : , : Springer International Publishing : , : Imprint : Springer, , 2015
Descrizione fisica 1 online resource (XXI, 550 p. 49 illus., 7 illus. in color.)
Disciplina 610.724
Soggetto topico Assaigs clínics
Statistics
Public health
Epidemiology
Cancer - Research
Oncology
Statistics for Life Sciences, Medicine, Health Sciences
Public Health
Cancer Research
Soggetto genere / forma Llibres electrònics
ISBN 3-319-18539-X
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Introduction to Clinical Trials -- Ethical Issues -- What is the Question? -- Study Population -- Basic Study Design -- The Randomization Process -- Blinding -- Sample Size -- Baseline Assessment -- Recruitment of Study Participants -- Data Collection and Quality Control -- Assessment and Reporting of Harm -- Assessment of Health Related Quality of Life -- Participant Adherence -- Survival Analysis -- Monitoring Committee Structure & Function -- Statistical Methods Used in Interim Monitoring -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials -- Regulatory Issues.
Record Nr. UNINA-9910299767003321
Friedman Lawrence M  
Cham : , : Springer International Publishing : , : Imprint : Springer, , 2015
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Principles and practice of clinical trials / / edited by Steven Piantadosi and Curtis L. Meinert
Principles and practice of clinical trials / / edited by Steven Piantadosi and Curtis L. Meinert
Pubbl/distr/stampa Cham, Switzerland : , : Springer, , [2022]
Descrizione fisica 1 online resource (2573 pages) : illustrations (some color)
Disciplina 610.727
Soggetto topico Clinical trials
Statistics
Clinical trials - Statistical methods
Assaigs clínics
Soggetto genere / forma Llibres electrònics
ISBN 3-319-52636-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Intro -- A Foreword to the Principles and Practice of Clinical Trials -- Preface -- Acknowledgments -- Contents -- About the Editors -- About the Section Editors -- Contributors -- Part I: Perspectives on Clinical Trials -- 1 Social and Scientific History of Randomized Controlled Trials -- Introduction -- Early History of Clinical Trials -- Refining Trial Methods in the Early Twentieth Century -- The Role of Governments in the Institutionalization of Randomized Controlled Trials -- Historical Trial Ethics -- RCTs and Evidence-Based Medicine -- The Globalization of RCTs and the Challenges of Similarities and Differences in Global Populations -- Social and Scientific Challenges in Randomized Controlled Trials -- Summary and Conclusion -- Key Facts -- Cross-References -- References -- 2 Evolution of Clinical Trials Science -- Introduction -- The Scientific MethodScience is the study of natural phenomena, which are accessible to both passive and active observation. P... -- Some Key Evolutionary Developments -- Ethics -- Governance ModelsRunning a clinical trial in the modern world is not simple and requires some unique governance features. Whil... -- Computerization -- Statistical Advances -- A Likely Future -- Final Comments -- Key Facts -- Cross-References -- References -- 3 Terminology: Conventions and Recommendations -- Introduction -- Clinical Trial -- Trial Versus Study -- Pilot Study Versus Feasibility Study -- Name of Trial -- Name of the Experimental Variable: Treatment Versus Intervention -- Name for Groups Represented by Experimental Variable: Study Group, Treatment Group, or Arm -- Persons Studied: Subject, Patient, or Participant -- Trial Protocol Versus Manual of Operations -- Blocking Versus Stratification and Quotafication -- Open -- Controlled -- Placebo -- Consent -- Randomization Versus Randomized -- Registration Versus Enrollment.
Single Center Trial Versus Multicenter Trial -- Multicenter Versus Cooperative Versus Collaborative -- Principal Investigator (PI) Versus Study Chair -- Clinical Investigator Versus Investigator -- Steering Committee Versus Executive Committee -- Data Monitoring Versus Data Monitoring Committee -- Random Versus Haphazard -- Primary Versus Secondary Outcomes -- Outcome Versus Endpoint -- Treatment Failure Versus Treatment Cessation -- Blind Versus Mask -- Lost to Followup -- Dropout -- Withdrawals -- Design Variable Versus Primary Outcome Measure -- Baseline Versus Baseline Period -- Screened Versus Enrolled -- End of Followup Versus End of Trial -- Analysis by Assigned Treatment Versus Per Protocol Analysis -- Bias -- Early Stop Versus Nominal Stop -- Summary -- References -- 4 Clinical Trials, Ethics, and Human Protections Policies -- Origins of Research Ethics -- Conception of Trials -- Design of Trials -- Risk/Benefit -- Justification of Therapeutic Procedures: Clinical Equipoise -- Justification of Demarcated Research Procedures -- Riskless Research, High Risk Research, Comparative Effectiveness Trials, and Ethics -- Maximizing Efficiencies -- Justice -- Fair Subject Selection -- Inclusion -- Trial Inception -- Respect for Persons -- Elements of Valid Informed Consent -- Research Without Informed Consent -- Informed Consent Documents -- Independent Review -- Conduct -- Trials and Ethics Across Time -- Reporting -- Publication and Results Deposition -- Methods and Outcome Reporting -- The Afterlife of Trials -- Synthesis -- Cross-References -- References -- 5 History of the Society for Clinical Trials -- Introduction -- Background: 1967-1972 -- Steps in the Creation of the Society for Clinical Trials -- Meetings of Coordinating Center Personnel -- Coordinating Center Models Project -- National Conference on Clinical Trials Methodology.
Journals of the Society for Clinical Trials -- International Participation -- Summary and Conclusion -- References -- Part II: Conduct and Management -- 6 Investigator Responsibilities -- Introduction -- Definitions -- Research -- Investigators -- Overall Responsibilities of Investigators -- Research Study Design and Conduct -- Design -- Conduct -- Qualifications, Training, and Delegation of Tasks -- The Clinical Research Team -- Accountability of Investigational Agents -- Data Collection, Research Record Maintenance, and Retention -- Reporting of Research Findings -- Safeguards to Protect Research Participants -- Adverse Event Reporting -- Safety Oversight -- IRB Requirements -- Informed Consent Process -- Protocol Noncompliance and Research Misconduct -- Protocol Noncompliance -- Research Misconduct -- Summary and Conclusion -- Key Facts -- Regulations and Policies -- Cross-References -- References -- 7 Centers Participating in Multicenter Trials -- Introduction -- Roles and Functions of Resource Centers -- Coordinating Centers -- Clinical Coordinating Centers -- Data Coordinating Centers -- Other Resource Centers -- Clinical Centers -- The Implementation Phase -- Organizing the Site -- Assembling the Study Team -- Attributes of the Principal Investigator -- Attributes of the Clinical Coordinator -- Interactions with the Team -- Ethical Approval -- Organization Binders/Files -- Certification and Training -- Participant Enrollment Phase -- Recruitment -- Screening and Randomization -- Treatment and Follow-Up Phase -- Scheduling and Communications -- Adverse Events -- Data Collection -- Data Management -- Site Visits -- Study Meetings -- Participant Closeout Phase -- Final Follow-Up Visit -- Post-Funding Phase -- Dissemination of Study Results -- Summary and Conclusion -- Key Facts -- Cross-References -- References.
8 Qualifications of the Research Staff -- Introduction -- History of Clinical Research Staff -- Staff Qualifications -- Training -- Credentialing Organizations in Clinical Research -- Summary -- Key Facts -- Cross-References -- References -- 9 Multicenter and Network Trials -- Introduction -- Multicenter Clinical Trials -- Formation -- Trial Leadership -- Design Considerations -- Coordination of Study Activities and Logistics Between Sites -- Clinical Trial Networks -- Summary and Conclusions -- Key Facts -- Cross-References -- References -- 10 Principles of Protocol Development -- Introduction -- Administrative Information: SPIRIT Checklist Items 1-5d -- Background and Rationale and Objectives: SPIRIT Checklist Items 6-7 -- Trial Design: SPIRIT Checklist Item 8 -- Participants, Interventions, and Outcomes: SPIRIT Checklist Items 9-17b -- Participants -- Interventions -- Outcomes -- Participant Timeline, Sample Size Recruitment (Items 13-15) -- Sample Size -- Recruitment -- Assignment of Interventions (for Controlled Trials): Spirit Checklist Items 16-17b -- Data Collection/Management and Analysis: SPIRIT Checklist Items 18a-20c -- Data Collection -- Data Management -- Statistical Analysis -- Monitoring: SPIRIT Checklist Items 21-23 -- Data Monitoring -- Efficacy -- Harm -- Quality Assurance (Monitoring/Auditing) -- Ethics and Dissemination: SPIRIT Checklist Items 24-31c -- Ethics -- Dissemination -- Conclusion -- References -- 11 Procurement and Distribution of Study Medicines -- Introduction -- Procurement of Investigational Product -- Investigational Product Procurement Planning -- Use of a Generic Drug -- Considerations for IP Procurement/Manipulation in Blinded Trials -- Impact of IP-Related Factors: Controlled Substances -- Identification of Qualified Vendors -- Packaging Considerations.
Manufacturing and Packaging Considerations for Blinded Trials -- International Clinical Trials -- Distribution of Investigational Product -- Documents to Support Release of IP to Qualified Sites -- Use of Controlled Substances in Clinical Trials -- IP Inventory Management for Complex Study Designs -- IP Accountability -- Shipping and Receipt of IP -- Quality Assurance -- Summary and Conclusion -- Key Facts -- References -- 12 Selection of Study Centers and Investigators -- Introduction -- Site and Investigator Selection Plan -- Site Selection -- Facility Resources -- Site and Process Flow -- Administrative Considerations -- Recruitment Potential -- Regulatory and Ethics Requirements -- Investigator Selection -- Investigator Responsibilities -- Investigator Qualification -- Investigative Team Considerations -- Investigator Equipoise -- Investigator Motivation -- Site Team Dynamics -- Research Experience and Past Performance -- Site and Investigator Selection Methods -- Surveys and Questionnaires -- Site Qualification Visit -- Summary -- Key Facts -- References -- 13 Design and Development of the Study Data System -- Introduction -- Descriptive Overview -- System Components: The Naming of Parts -- The Rise of the eRDC Workflow -- Deployment Options and Implications -- Constructing the Study Definition -- Overview -- Working from the Protocol -- Working Up the Functional Specification -- ``User Acceptance Testing´´ -- Final Approval of the Specification -- Using Data Standards -- Validating the Specification and Final Release -- Development and Testing Environments -- The Study Data System in the Longer Term -- Change Management -- Exporting the Data for Analysis -- Summary and Conclusion -- Key Facts -- Cross-References -- References -- 14 Implementing the Trial Protocol -- Introduction -- Protocol Development -- Site Selection, Feasibility, and Set Up.
Site Characteristics.
Record Nr. UNINA-9910585772403321
Cham, Switzerland : , : Springer, , [2022]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Principles and practice of clinical trials / / edited by Steven Piantadosi and Curtis L. Meinert
Principles and practice of clinical trials / / edited by Steven Piantadosi and Curtis L. Meinert
Pubbl/distr/stampa Cham, Switzerland : , : Springer, , [2022]
Descrizione fisica 1 online resource (2573 pages) : illustrations (some color)
Disciplina 610.727
Soggetto topico Clinical trials
Statistics
Clinical trials - Statistical methods
Assaigs clínics
Soggetto genere / forma Llibres electrònics
ISBN 3-319-52636-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Intro -- A Foreword to the Principles and Practice of Clinical Trials -- Preface -- Acknowledgments -- Contents -- About the Editors -- About the Section Editors -- Contributors -- Part I: Perspectives on Clinical Trials -- 1 Social and Scientific History of Randomized Controlled Trials -- Introduction -- Early History of Clinical Trials -- Refining Trial Methods in the Early Twentieth Century -- The Role of Governments in the Institutionalization of Randomized Controlled Trials -- Historical Trial Ethics -- RCTs and Evidence-Based Medicine -- The Globalization of RCTs and the Challenges of Similarities and Differences in Global Populations -- Social and Scientific Challenges in Randomized Controlled Trials -- Summary and Conclusion -- Key Facts -- Cross-References -- References -- 2 Evolution of Clinical Trials Science -- Introduction -- The Scientific MethodScience is the study of natural phenomena, which are accessible to both passive and active observation. P... -- Some Key Evolutionary Developments -- Ethics -- Governance ModelsRunning a clinical trial in the modern world is not simple and requires some unique governance features. Whil... -- Computerization -- Statistical Advances -- A Likely Future -- Final Comments -- Key Facts -- Cross-References -- References -- 3 Terminology: Conventions and Recommendations -- Introduction -- Clinical Trial -- Trial Versus Study -- Pilot Study Versus Feasibility Study -- Name of Trial -- Name of the Experimental Variable: Treatment Versus Intervention -- Name for Groups Represented by Experimental Variable: Study Group, Treatment Group, or Arm -- Persons Studied: Subject, Patient, or Participant -- Trial Protocol Versus Manual of Operations -- Blocking Versus Stratification and Quotafication -- Open -- Controlled -- Placebo -- Consent -- Randomization Versus Randomized -- Registration Versus Enrollment.
Single Center Trial Versus Multicenter Trial -- Multicenter Versus Cooperative Versus Collaborative -- Principal Investigator (PI) Versus Study Chair -- Clinical Investigator Versus Investigator -- Steering Committee Versus Executive Committee -- Data Monitoring Versus Data Monitoring Committee -- Random Versus Haphazard -- Primary Versus Secondary Outcomes -- Outcome Versus Endpoint -- Treatment Failure Versus Treatment Cessation -- Blind Versus Mask -- Lost to Followup -- Dropout -- Withdrawals -- Design Variable Versus Primary Outcome Measure -- Baseline Versus Baseline Period -- Screened Versus Enrolled -- End of Followup Versus End of Trial -- Analysis by Assigned Treatment Versus Per Protocol Analysis -- Bias -- Early Stop Versus Nominal Stop -- Summary -- References -- 4 Clinical Trials, Ethics, and Human Protections Policies -- Origins of Research Ethics -- Conception of Trials -- Design of Trials -- Risk/Benefit -- Justification of Therapeutic Procedures: Clinical Equipoise -- Justification of Demarcated Research Procedures -- Riskless Research, High Risk Research, Comparative Effectiveness Trials, and Ethics -- Maximizing Efficiencies -- Justice -- Fair Subject Selection -- Inclusion -- Trial Inception -- Respect for Persons -- Elements of Valid Informed Consent -- Research Without Informed Consent -- Informed Consent Documents -- Independent Review -- Conduct -- Trials and Ethics Across Time -- Reporting -- Publication and Results Deposition -- Methods and Outcome Reporting -- The Afterlife of Trials -- Synthesis -- Cross-References -- References -- 5 History of the Society for Clinical Trials -- Introduction -- Background: 1967-1972 -- Steps in the Creation of the Society for Clinical Trials -- Meetings of Coordinating Center Personnel -- Coordinating Center Models Project -- National Conference on Clinical Trials Methodology.
Journals of the Society for Clinical Trials -- International Participation -- Summary and Conclusion -- References -- Part II: Conduct and Management -- 6 Investigator Responsibilities -- Introduction -- Definitions -- Research -- Investigators -- Overall Responsibilities of Investigators -- Research Study Design and Conduct -- Design -- Conduct -- Qualifications, Training, and Delegation of Tasks -- The Clinical Research Team -- Accountability of Investigational Agents -- Data Collection, Research Record Maintenance, and Retention -- Reporting of Research Findings -- Safeguards to Protect Research Participants -- Adverse Event Reporting -- Safety Oversight -- IRB Requirements -- Informed Consent Process -- Protocol Noncompliance and Research Misconduct -- Protocol Noncompliance -- Research Misconduct -- Summary and Conclusion -- Key Facts -- Regulations and Policies -- Cross-References -- References -- 7 Centers Participating in Multicenter Trials -- Introduction -- Roles and Functions of Resource Centers -- Coordinating Centers -- Clinical Coordinating Centers -- Data Coordinating Centers -- Other Resource Centers -- Clinical Centers -- The Implementation Phase -- Organizing the Site -- Assembling the Study Team -- Attributes of the Principal Investigator -- Attributes of the Clinical Coordinator -- Interactions with the Team -- Ethical Approval -- Organization Binders/Files -- Certification and Training -- Participant Enrollment Phase -- Recruitment -- Screening and Randomization -- Treatment and Follow-Up Phase -- Scheduling and Communications -- Adverse Events -- Data Collection -- Data Management -- Site Visits -- Study Meetings -- Participant Closeout Phase -- Final Follow-Up Visit -- Post-Funding Phase -- Dissemination of Study Results -- Summary and Conclusion -- Key Facts -- Cross-References -- References.
8 Qualifications of the Research Staff -- Introduction -- History of Clinical Research Staff -- Staff Qualifications -- Training -- Credentialing Organizations in Clinical Research -- Summary -- Key Facts -- Cross-References -- References -- 9 Multicenter and Network Trials -- Introduction -- Multicenter Clinical Trials -- Formation -- Trial Leadership -- Design Considerations -- Coordination of Study Activities and Logistics Between Sites -- Clinical Trial Networks -- Summary and Conclusions -- Key Facts -- Cross-References -- References -- 10 Principles of Protocol Development -- Introduction -- Administrative Information: SPIRIT Checklist Items 1-5d -- Background and Rationale and Objectives: SPIRIT Checklist Items 6-7 -- Trial Design: SPIRIT Checklist Item 8 -- Participants, Interventions, and Outcomes: SPIRIT Checklist Items 9-17b -- Participants -- Interventions -- Outcomes -- Participant Timeline, Sample Size Recruitment (Items 13-15) -- Sample Size -- Recruitment -- Assignment of Interventions (for Controlled Trials): Spirit Checklist Items 16-17b -- Data Collection/Management and Analysis: SPIRIT Checklist Items 18a-20c -- Data Collection -- Data Management -- Statistical Analysis -- Monitoring: SPIRIT Checklist Items 21-23 -- Data Monitoring -- Efficacy -- Harm -- Quality Assurance (Monitoring/Auditing) -- Ethics and Dissemination: SPIRIT Checklist Items 24-31c -- Ethics -- Dissemination -- Conclusion -- References -- 11 Procurement and Distribution of Study Medicines -- Introduction -- Procurement of Investigational Product -- Investigational Product Procurement Planning -- Use of a Generic Drug -- Considerations for IP Procurement/Manipulation in Blinded Trials -- Impact of IP-Related Factors: Controlled Substances -- Identification of Qualified Vendors -- Packaging Considerations.
Manufacturing and Packaging Considerations for Blinded Trials -- International Clinical Trials -- Distribution of Investigational Product -- Documents to Support Release of IP to Qualified Sites -- Use of Controlled Substances in Clinical Trials -- IP Inventory Management for Complex Study Designs -- IP Accountability -- Shipping and Receipt of IP -- Quality Assurance -- Summary and Conclusion -- Key Facts -- References -- 12 Selection of Study Centers and Investigators -- Introduction -- Site and Investigator Selection Plan -- Site Selection -- Facility Resources -- Site and Process Flow -- Administrative Considerations -- Recruitment Potential -- Regulatory and Ethics Requirements -- Investigator Selection -- Investigator Responsibilities -- Investigator Qualification -- Investigative Team Considerations -- Investigator Equipoise -- Investigator Motivation -- Site Team Dynamics -- Research Experience and Past Performance -- Site and Investigator Selection Methods -- Surveys and Questionnaires -- Site Qualification Visit -- Summary -- Key Facts -- References -- 13 Design and Development of the Study Data System -- Introduction -- Descriptive Overview -- System Components: The Naming of Parts -- The Rise of the eRDC Workflow -- Deployment Options and Implications -- Constructing the Study Definition -- Overview -- Working from the Protocol -- Working Up the Functional Specification -- ``User Acceptance Testing´´ -- Final Approval of the Specification -- Using Data Standards -- Validating the Specification and Final Release -- Development and Testing Environments -- The Study Data System in the Longer Term -- Change Management -- Exporting the Data for Analysis -- Summary and Conclusion -- Key Facts -- Cross-References -- References -- 14 Implementing the Trial Protocol -- Introduction -- Protocol Development -- Site Selection, Feasibility, and Set Up.
Site Characteristics.
Record Nr. UNISA-996483154503316
Cham, Switzerland : , : Springer, , [2022]
Materiale a stampa
Lo trovi qui: Univ. di Salerno
Opac: Controlla la disponibilità qui