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Biosimilars and biologics : implementation and monitoring in a healthcare setting / / Steven Lucio
| Biosimilars and biologics : implementation and monitoring in a healthcare setting / / Steven Lucio |
| Autore | Lucio Steven |
| Pubbl/distr/stampa | American Society of Health-System Pharmacists |
| Disciplina | 615.1/9 |
| Soggetto topico |
Biosimilar Pharmaceuticals
Drug Compounding Drug Monitoring |
| ISBN | 1-58528-581-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | A new type of blockbuster : the growth of biologics -- Déjá vu or something new? : comparing the generics and biosimilars experiences -- Bugs and drugs, and yeast and mice, and Chinese hamsters -- The $250 billion pyramid : analytics in biosimilarity determination -- The global biosimilars experience -- The American biosimilar experience : red, white, and possibly interchangeable -- Biosimilar clinical trial requirements -- Immunogenicity and pharmacovigilance in the biosimilar era -- The patent dance and the exclusivity shuffle -- Defining biosimilar value and other impossible tasks -- Biosimilar formulary management strategies. |
| Altri titoli varianti | Biosimilars and Biologics |
| Record Nr. | UNINA-9910796836603321 |
Lucio Steven
|
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| American Society of Health-System Pharmacists | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Biosimilars and biologics : implementation and monitoring in a healthcare setting / / Steven Lucio
| Biosimilars and biologics : implementation and monitoring in a healthcare setting / / Steven Lucio |
| Autore | Lucio Steven |
| Pubbl/distr/stampa | American Society of Health-System Pharmacists |
| Disciplina | 615.1/9 |
| Soggetto topico |
Biosimilar Pharmaceuticals
Drug Compounding Drug Monitoring |
| ISBN | 1-58528-581-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | A new type of blockbuster : the growth of biologics -- Déjá vu or something new? : comparing the generics and biosimilars experiences -- Bugs and drugs, and yeast and mice, and Chinese hamsters -- The $250 billion pyramid : analytics in biosimilarity determination -- The global biosimilars experience -- The American biosimilar experience : red, white, and possibly interchangeable -- Biosimilar clinical trial requirements -- Immunogenicity and pharmacovigilance in the biosimilar era -- The patent dance and the exclusivity shuffle -- Defining biosimilar value and other impossible tasks -- Biosimilar formulary management strategies. |
| Altri titoli varianti | Biosimilars and Biologics |
| Record Nr. | UNINA-9910809359803321 |
|
Lucio Steven
|
||
| American Society of Health-System Pharmacists | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmacovigilance Essentials : Advances, Challenges and Global Perspectives
| Pharmacovigilance Essentials : Advances, Challenges and Global Perspectives |
| Autore | Nandave Mukesh |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Springer Nature, 2024 |
| Descrizione fisica | 1 online resource (478 pages) |
| Disciplina | 363.19463 |
| Altri autori (Persone) | KumarAnoop |
| Soggetto topico |
Pharmacovigilance
Drug Monitoring Adverse Drug Reaction Reporting Systems |
| ISBN | 981-9989-49-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro -- Foreword -- Preface -- Contents -- Editors and Contributors -- About the Editors -- Contributors -- Abbreviations -- 1: Introduction to Pharmacovigilance -- 1.1 Introduction -- 1.2 Needs and Objectives of Pharmacovigilance -- 1.2.1 Needs -- 1.2.2 Objectives -- 1.3 Pharmacovigilance in Drug Development -- 1.4 Classification -- 1.4.1 Vaccine Vigilance -- 1.4.2 Herbovigilance -- 1.4.3 Materiovigilance -- 1.4.4 Hemovigilance -- 1.5 Case Reporting -- 1.5.1 The "4 Ws" of Case Reporting -- 1.5.2 Issues and Possible Solutions in Reporting -- 1.6 Causality Assessment (CA) -- 1.6.1 Purpose of Causality Assessment -- 1.6.2 Tools -- 1.6.3 Measures Taken by Regulatory Bodies -- 1.6.4 Challenges -- 1.7 Management of ADRs -- 1.8 Conclusion -- References -- 2: History of Pharmacovigilance -- 2.1 Introduction -- 2.2 Historical Background -- 2.3 Development of Pharmacovigilance in the USA -- 2.3.1 Sulfanilamide Tragedy -- 2.3.2 Regulatory Action Taken After Sulfanilamide Tragedy -- 2.3.2.1 Federal Food, Drug, and Cosmetic Act (FD& -- C Act) -- 2.3.3 Thalidomide Disaster -- 2.3.4 Regulatory Actions Taken After the Thalidomide Tragedy -- 2.3.4.1 Kefauver Harris Amendment -- 2.3.4.2 FDA 3-Segment Study Designs -- 2.3.4.3 International Drug Monitoring Programme -- 2.3.4.4 Drug Efficacy Safety Implementation Programme -- 2.3.4.5 Prescription Drug User Fee Act (PDUFA) -- 2.3.4.6 MedWatch -- 2.3.4.7 US FDA Modernization Act (FDAMA) -- 2.3.4.8 USFDA Amendment of 2007 -- 2.3.4.9 Purple Book -- 2.4 Development of Pharmacovigilance in Europe -- 2.4.1 Thalidomide Disaster -- 2.4.2 Regulatory Action Taken After the Thalidomide Disaster -- 2.4.2.1 Committee for Safety of Drugs -- 2.4.2.2 EC Directive 65/65 -- 2.4.2.3 European Medicines Agency -- 2.4.3 Theralizumab (TGN1412) Tragedy.
2.4.4 Regulatory Action Was Taken After the TGN1412 Tragedy -- 2.5 Development of Pharmacovigilance in India -- 2.6 Development of Pharmacovigilance in Non-European Countries -- 2.6.1 Pharmacovigilance in Korea -- 2.6.2 Pharmacovigilance in China -- 2.7 Some Recent Tragedies -- 2.7.1 Heparin Contamination -- 2.7.2 Counterfeit Avastin -- 2.7.3 Ranitidine Tragedy -- 2.7.4 Digene Recall -- 2.8 Conclusion -- References -- 3: Databases Used in Pharmacovigilance Across the Globe -- 3.1 Introduction -- 3.2 Databases Used in Pharmacovigilance -- 3.3 National Pharmacovigilance Databases Used by the Different Countries -- 3.3.1 VigiBase -- 3.3.1.1 Advantages -- 3.3.1.2 Limitations -- 3.3.2 EudraVigilance -- 3.3.2.1 Advantages -- 3.3.2.2 Limitations -- 3.3.3 FDA Adverse Event Reporting System (FAERS) -- 3.3.3.1 Advantages -- 3.3.3.2 Limitations -- 3.3.4 Indicator-Based Pharmacovigilance Assessment Tool (IPAT) -- 3.3.4.1 Advantages -- 3.3.4.2 Limitations -- 3.3.5 Database of Adverse Event Notifications (DAEN) -- 3.3.5.1 Advantages -- 3.3.5.2 Limitations -- 3.3.6 Canada Vigilance Adverse Reaction Online Database -- 3.3.6.1 Advantages -- 3.3.6.2 Limitations -- 3.3.7 The Korea Adverse Event Reporting System (KAERS) -- 3.3.7.1 Advantages -- 3.3.7.2 Limitations -- 3.4 Commercially Used Pharmacovigilance Database -- 3.4.1 AB Cube: Safety Easy -- 3.4.1.1 Characteristics of AB Cube: Safety Easy -- 3.4.2 Oracle: Argus Safety Database -- 3.4.2.1 Characteristics of AB Cube: Safety Easy -- 3.4.3 Aris Global: ARISg/LifeSphere Safety -- 3.4.3.1 Characteristics of Aris Global: ARISg/LifeSphere Safety -- 3.4.4 Ennov Pharmacovigilance Suite -- 3.4.4.1 Characteristics of Ennov Pharmacovigilance Suite -- 3.4.5 BaseCon -- 3.4.5.1 Characteristics of BaseCon -- 3.5 Conclusion -- References -- 4: Processing of ADRs. 4.1 Processing of ADRs -- 4.2 Collection of ADRs -- 4.3 Processing of Adverse Drug Reactions (ADRs) -- 4.3.1 Case Identification and Collection -- 4.3.2 Data Entry -- 4.3.3 Quality Checks -- 4.3.4 Individual Case Safety Reports (ICSRs) Creation -- 4.3.5 Signal Detection and Analysis -- 4.3.6 Signal Evaluation and Refinement -- 4.3.7 Reporting to Regulatory Authorities -- 4.3.8 Risk Communication and Management -- 4.3.9 Continuous Monitoring and Assessment -- 4.4 Reporting of ADRs in India -- 4.4.1 Reporting Requirements -- 4.4.2 Where to File a Report -- 4.4.3 How to File a Report -- 4.4.4 To Whom Report is Submitted -- 4.5 Selection of Database -- 4.6 Validity of ADRs -- 4.6.1 Validity of ADRS Form -- 4.6.2 Seriousness of ADRs -- 4.7 Triage of Case -- 4.7.1 The Triage Procedure Is Described in Detail Below -- 4.8 Listedness of Cases -- 4.8.1 Categories of Listedness -- 4.9 Medical Coding -- 4.9.1 Most Commonly Used Medical Dictionaries -- 4.9.2 Medical Dictionary for Regulatory Activities (MedDRA) -- 4.9.3 MedDRA Employs a Hierarchical Framework Comprising Five Primary Tiers -- 4.9.3.1 System-Organ Class (SOC) -- 4.9.3.2 High-Level Group Term (HLGT) -- 4.9.3.3 High-Level Term (HLT) -- 4.9.3.4 Preferred Term (PT) -- 4.9.3.5 Lowest Level Term (LLT) -- 4.9.3.6 Advantage -- 4.9.4 Standardized MedDRA Queries (SMQs) -- 4.9.4.1 Advantages -- 4.9.5 WHODRUG Global -- 4.9.5.1 Advantages -- 4.9.6 World Health Organization Adverse Reactions Terminology (WHO-ART) -- 4.9.6.1 Structure of WHO-ART -- 4.9.6.2 Advantages -- 4.9.7 WHO-DDE: World Health Organization Drug Dictionary Enhanced -- 4.9.7.1 Codes Serve the Purpose of Distinguishing Distinct Characteristics of a Product -- 4.9.7.2 Improved Accuracy and Reporting of Clinical Trial and Safety Data. 4.9.7.3 On-Going Expansion Encompassing More Products, Countries and Services -- 4.9.7.4 Related UMC Drug Dictionary Offerings -- 4.9.7.5 Advantages -- 4.9.8 COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms -- 4.9.8.1 Overview of COSTART -- 4.9.8.2 Advantages -- 4.9.9 ICD-9-CM: International Classification of Disease, Ninth Revision, Clinical Modification -- 4.9.9.1 Development and Purpose -- 4.9.9.2 Structure and Coding System -- 4.9.9.3 Utilization in Healthcare -- 4.9.9.4 Advantages -- 4.9.10 WHO Herbal Dictionary (WHO-HD) -- 4.9.10.1 Advantages -- 4.10 Causality Assessment System -- 4.10.1 Principles of Causality Assessment -- 4.10.2 Basic Standards for Causality -- 4.10.3 Causality Assessment Determination Methods -- 4.10.3.1 Clinical Judgment/Global Introspection -- 4.10.3.2 WHO UPSALA Monitoring Centre (UMC) Method -- 4.10.4 Algorithmic Methods -- 4.10.4.1 Naranjo Scale -- 4.10.5 Probabilistic Method -- 4.10.5.1 Bayesian Method -- 4.10.5.2 Bayes' Theorem -- 4.10.5.3 Bayesian Methods in PV -- 4.11 Conclusion -- References -- 5: Aggregate Reporting -- 5.1 Introduction -- 5.2 Importance -- 5.2.1 Patient Safety -- 5.2.2 Signal Detection -- 5.2.3 Risk Management -- 5.2.4 Regulatory Compliance -- 5.2.5 Decision-Making -- 5.2.6 Public Health Monitoring -- 5.2.7 Long-Term Safety Assessment -- 5.2.8 Communication with Healthcare Professionals -- 5.2.9 Research and Development -- 5.2.10 Global Monitoring -- 5.3 Types of Aggregate Reporting -- 5.3.1 Periodic Safety Update Report (PSUR) -- 5.3.2 Periodic Adverse Drug Experience Report (PADER) -- 5.3.3 Periodic Benefit Risk Evaluation Report (PBRER) -- 5.3.4 Development Safety Updates Report (DSUR) -- 5.4 Significance -- 5.5 Challenges -- 5.5.1 Data Quality -- 5.5.2 Appropriateness -- 5.5.3 Signal Detection and Evaluation. 5.5.4 Regulatory Acquiescence -- 5.5.5 Risk Minimization and Management -- 5.5.6 Resource Allocation -- 5.5.7 Communication and Collaboration -- 5.5.8 Updating Safety Databases -- 5.6 Conclusion -- References -- 6: Reporting of ADRs Across the Globe: India, USA, EU, and Non-EU -- 6.1 Introduction -- 6.2 Overview of ADR Reporting -- 6.2.1 Definition and Importance of ADR Reporting -- 6.2.2 Objectives and Benefits of ADR Reporting -- 6.3 ADR Reporting in India -- 6.3.1 Regulatory Framework and Authorities -- 6.3.2 Structure of ADR Reporting System -- 6.3.3 Challenges and Improvements -- 6.4 ADR Reporting in the United States -- 6.4.1 Regulatory Framework and Authorities -- 6.4.2 Structure of ADR Reporting System -- 6.4.3 Challenges and Improvements -- 6.5 ADR Reporting in the European Union -- 6.5.1 Regulatory Framework and Authorities -- 6.5.2 Structure of ADR Reporting System -- 6.5.3 Challenges and Improvements -- 6.6 ADR Reporting in the Non-European Union -- 6.6.1 Regulatory Framework and Authorities -- 6.6.2 Structure of ADR Reporting System -- 6.6.3 Challenges and Improvements -- 6.7 Comparative Analysis and Lessons Learned -- 6.8 Case Studies or Examples of ADR Reporting in India, US, EU, and Non-EU -- 6.9 Future Perspectives and Recommendations -- 6.9.1 Advancements in ADR Reporting Technology -- 6.10 Collaboration and Information Sharing Among Regions -- 6.11 Recommendations for Enhancing ADR Reporting Globally -- 6.12 Conclusion -- References -- 7: Pharmacovigilance System in India -- 7.1 Introduction -- 7.1.1 History of Pharmacovigilance System in India -- 7.2 Advantages of Pharmacovigilance System in India -- 7.3 National Pharmacovigilance Programme -- 7.3.1 Peripheral Pharmacovigilance Centers -- 7.3.2 Regional Pharmacovigilance Centers -- 7.3.3 Zonal Pharmacovigilance Centers. 7.4 Pharmacovigilance Programme of India (PvPI). |
| Record Nr. | UNINA-9910853988703321 |
|
Nandave Mukesh
|
||
| Springer Nature, 2024 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines [[electronic resource]]
| A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines [[electronic resource]] |
| Pubbl/distr/stampa | Geneva, : World Health Organization, 2008 |
| Descrizione fisica | 1 online resource (175 p.) |
| Disciplina | 600 |
| Soggetto topico |
Adverse Drug Reaction Reporting Systems
Antimalarials -- standards Antimalarials Drug Monitoring Drug Utilization Review -- methods Pharmacoepidemiology -- methods Product Surveillance, Postmarketing Drug monitoring - Side effects Drug Utilization Review Pharmacoepidemiology Methods Utilization Review Antiprotozoal Agents Investigative Techniques Drug Utilization Pharmacology Epidemiology Evaluation Studies as Topic Monitoring, Physiologic Quality of Health Care Quality Assurance, Health Care Public Health Health Occupations Biological Science Disciplines Analytical, Diagnostic and Therapeutic Techniques and Equipment Diagnostic Techniques and Procedures Pharmacy Administration Antiparasitic Agents Disciplines and Occupations Medicine Health Services Administration Natural Science Disciplines Health Care Quality, Access, and Evaluation Organization and Administration Diagnosis Anti-Infective Agents Therapeutic Uses Health Care Pharmacologic Actions Chemical Actions and Uses Chemicals and Drugs Pharmacy, Therapeutics, & Pharmacology Health & Biological Sciences |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-282-25005-1
9786612250057 92-4-068371-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
COVER; TITLE; COPYRIGHT; TABLE OF CONTENTS; FOREWORD; PART 1: GUIDANCE DOCUMENT ON CHARACTERIZING AND COMMUNICATING UNCERTAINTY IN EXPOSURE ASSESSMENT; ACKNOWLEDGEMENTS; MEMBERS OF THE WHO/IPCS WORKING GROUP ON UNCERTAINTY IN EXPOSURE ASSESSMENT; LIST OF ACRONYMS AND ABBREVIATIONS; EXECUTIVE SUMMARY; 1. INTRODUCTION; 2. CONTEXT, CONCEPTS AND DEFINITIONS; 3. SOURCES OF UNCERTAINTY; 4. TIERED APPROACH TO UNCERTAINTY ANALYSIS; 5. UNCERTAINTY CHARACTERIZATION METHODS, INTERPRETATION AND USE; 6. COMMUNICATION; 7. CONCLUSIONS; 8. REFERENCES; GLOSSARY OF TERMS
ANNEX 1: CASE-STUDY-QUALITATIVE UNCERTAINTY ANALYSISAppendix 1: Background for case-study; ANNEX 2: CASE-STUDY-QUANTITATIVE UNCERTAINTY ANALYSIS; PART 2: HALLMARKS OF DATA QUALITY IN CHEMICAL EXPOSURE ASSESSMENT; PREPARATION OF THE DOCUMENT; 1. INTRODUCTION; 2. WHAT DO WE MEAN BY "DATA" IN EXPOSURE ASSESSMENT?; 3. TOWARDS A BROADER DEFINITION OF QUALITY IN EXPOSURE ASSESSMENT: HALLMARKS OF DATA QUALITY; 4. FROM EXPOSURE DATA QUALITY TO THE QUALITY OF EXPOSURE ASSESSMENTS; 5. CONCLUSIONS; 6. REFERENCES; Back Cover |
| Altri titoli varianti | Practical Handbook on the Pharmacovigilance of Antimalarial Medicines |
| Record Nr. | UNISA-996320248803316 |
| Geneva, : World Health Organization, 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines [[electronic resource]]
| A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines [[electronic resource]] |
| Pubbl/distr/stampa | Geneva, : World Health Organization, 2008 |
| Descrizione fisica | 1 online resource (175 p.) |
| Disciplina | 600 |
| Soggetto topico |
Adverse Drug Reaction Reporting Systems
Antimalarials -- standards Antimalarials Drug Monitoring Drug Utilization Review -- methods Pharmacoepidemiology -- methods Product Surveillance, Postmarketing Drug monitoring - Side effects Drug Utilization Review Pharmacoepidemiology Methods Utilization Review Antiprotozoal Agents Investigative Techniques Drug Utilization Pharmacology Epidemiology Evaluation Studies as Topic Monitoring, Physiologic Quality of Health Care Quality Assurance, Health Care Public Health Health Occupations Biological Science Disciplines Analytical, Diagnostic and Therapeutic Techniques and Equipment Diagnostic Techniques and Procedures Pharmacy Administration Antiparasitic Agents Disciplines and Occupations Medicine Health Services Administration Natural Science Disciplines Health Care Quality, Access, and Evaluation Organization and Administration Diagnosis Anti-Infective Agents Therapeutic Uses Delivery of Health Care Pharmacologic Actions Chemical Actions and Uses Chemicals and Drugs Pharmacy, Therapeutics, & Pharmacology Health & Biological Sciences |
| ISBN |
1-282-25005-1
9786612250057 92-4-068371-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
COVER; TITLE; COPYRIGHT; TABLE OF CONTENTS; FOREWORD; PART 1: GUIDANCE DOCUMENT ON CHARACTERIZING AND COMMUNICATING UNCERTAINTY IN EXPOSURE ASSESSMENT; ACKNOWLEDGEMENTS; MEMBERS OF THE WHO/IPCS WORKING GROUP ON UNCERTAINTY IN EXPOSURE ASSESSMENT; LIST OF ACRONYMS AND ABBREVIATIONS; EXECUTIVE SUMMARY; 1. INTRODUCTION; 2. CONTEXT, CONCEPTS AND DEFINITIONS; 3. SOURCES OF UNCERTAINTY; 4. TIERED APPROACH TO UNCERTAINTY ANALYSIS; 5. UNCERTAINTY CHARACTERIZATION METHODS, INTERPRETATION AND USE; 6. COMMUNICATION; 7. CONCLUSIONS; 8. REFERENCES; GLOSSARY OF TERMS
ANNEX 1: CASE-STUDY-QUALITATIVE UNCERTAINTY ANALYSISAppendix 1: Background for case-study; ANNEX 2: CASE-STUDY-QUANTITATIVE UNCERTAINTY ANALYSIS; PART 2: HALLMARKS OF DATA QUALITY IN CHEMICAL EXPOSURE ASSESSMENT; PREPARATION OF THE DOCUMENT; 1. INTRODUCTION; 2. WHAT DO WE MEAN BY "DATA" IN EXPOSURE ASSESSMENT?; 3. TOWARDS A BROADER DEFINITION OF QUALITY IN EXPOSURE ASSESSMENT: HALLMARKS OF DATA QUALITY; 4. FROM EXPOSURE DATA QUALITY TO THE QUALITY OF EXPOSURE ASSESSMENTS; 5. CONCLUSIONS; 6. REFERENCES; Back Cover |
| Altri titoli varianti | Practical Handbook on the Pharmacovigilance of Antimalarial Medicines |
| Record Nr. | UNINA-9910139903203321 |
| Geneva, : World Health Organization, 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
