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Beyond the implant : retrieval analysis methods for implant surveillance / / editors: William M. Mihalko, Jack E. Lemons, A. Seth Greenwald, and Steven M. Kurtz
| Beyond the implant : retrieval analysis methods for implant surveillance / / editors: William M. Mihalko, Jack E. Lemons, A. Seth Greenwald, and Steven M. Kurtz |
| Pubbl/distr/stampa | ASTM International |
| Disciplina | 617.5/80592 |
| Soggetto topico |
Joint Prosthesis
Arthroplasty, Replacement Product Surveillance, Postmarketing |
| Soggetto genere / forma | Congresses |
| ISBN | 0-8031-7658-9 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Current status of standards & unmet needs in retrieval analysis / A. Seth Greenwald, Christine Heim -- Retrieval analysis experience at a single center since 1970 and recommendations for future directions / Jack E. Lemons, Alan Eberhardt -- Medical device regulation and retrieval analysis / Jorge Ochoa, Ryan Siskey, Carrie Kuehn, Lauren Ciccarelli -- The need for standardization, terminology, and interfacing retrieval analysis with -- Registries / Kevin Ong, Ellen Chang -- Analysis techniques for polyethylene implants in total knee arthroplasty / William M. Mihalko, Christina Arnholt, Julie Lowell, Meredith Perkins, Steven Kurt -- Long term wear analysis of retrieved medially pivoting TKA inserts / Satya Nambu, Irina Timmerman -- Inflammatory cytokines as potential biomarkers for damage in total knee arthroplasty / William M. Mihalko, Meredith Perkins, Julie Lowell, Anita Kerkhof -- Using linear penetration as a surrogate measure for volumetric wear in retrieved TKR tibial inserts / Michel Laurent, Elmira Rad, Christopher Knowlton, Hannah Lundberg, Robin Pourzal, Markus Wimmer -- Novel heterodyne fringe projection technique for measuring volumetric wear in acetabular uhmwpe retrievals : a pilot study / Francisco Medel, Maria Povar, Jorg Santolaria -- Fretting corrosion and polyethylene damage mechanisms in modular dual mobility total hip arthroplasty / Hannah Spece, Daniel MacDonald, Michael Mont, Gwo-Chin Lee, Steven M. Kurtz -- Using coordinate measuring machine validated with white light interferometry to identify contributors material loss due to corrosion of modular junctions / Audrey Martin, Brian Mcgrory, Av Edidin, Douglas van Citters -- Imprinting and column damage on cocrmo head taper surfaces in total hip replacements / Deborah Hall, Stephanie McCarthy, Jonas Ehrich, Robert Urban, Alfons Fischer, Joshua Jacobs, Hannah Lundberg, Robin Pourzal -- Methods for characterization of edge wear in ceramic-on-ceramic acetabular cups / Radu Racasan, Darshil Kapadia, Luca Pagani, Mazen Al-Hajjar, Paul Bills -- Characterization of material loss from femoral stem taper surfaces through development of a responsive morphological filtering technique / Paul Bills, Karl Dransfield, Radu Racasan, Liam Blunt -- The use of semi-quantitative histology for reporting periprosthetic tissue features : a review / Pat Campbell, Michelle Nguyen, Nathaniel Yuan -- Characterization of cobalt in periprosthetic tissues and fluids : toxicological and clinical importance of standardizing quality analytical methods for differentiating cobalt partitioning on a molecular level / Brent Kerger, Russell Gerads, Hakan Gurleyuk, Joyce Tsuji -- Opportunities and challenges of retrieval analysis : the role of standardized periprosthetic tissue/fluid analysis for assessing an aggravated host response / Yelizaveta Torosyan, John Bowsher, Steven M. Kurtz, William M. Mihalko, Danica -- Marinac-dabic MRI as a biomarker for clinical problems in total joint arthroplasty : the role of retrieval analysis / Timothy Wright, Matthew Koff, Christina Esposito, Douglas Padgett, Thomas Bauer, Hollis Potter -- Genetic links to total joint arthroplasty (TJA) outcomes : a systematic review / William M. Mihalko, Meredith Perkins, Reed Butler, Lucas Tidwell, Weikuan gu -- The biomechanics and retrieval analysis of orthopaedic trauma devices / William M. Mihalko, Meredith Perkins, Julie Lowell, Dema Assaf, John Weinlein -- Lessons learned from retrieved total elbow implants / Timothy Wright, Darrick Lo, Joseph Lipman, Mark Figgie, Robert Hotchkiss. |
| Altri titoli varianti | Beyond the Implant |
| Record Nr. | UNINA-9910427530103321 |
| ASTM International | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design
| Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
| Descrizione fisica | 1 online resource (876 p.) |
| Disciplina | 363.19/463 |
| Soggetto topico |
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions Internationality Pharmacoepidemiology Product Surveillance, Postmarketing |
| ISBN |
1-118-82018-5
1-118-82014-2 1-118-82017-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title page; Copyright page; Contents; Contributors; Foreword; 1: Introduction: Updated from Second Edition; Background; Diagnosing Adverse Drug Reactions; Current Methods of Pharmacovigilance; Hypothesis-Generating Methods; Spontaneous Adverse Drug Reaction Reporting; Prescription-Event Monitoring; Other Hypothesis-Generating Methods; Hypothesis-Testing Methods; Conclusion; References; 2: History of Pharmacovigilance; Early History of Drug Safety; Recent History; Pre-1962; Turning Point: The Federal Food, Drug and Cosmetics Act; Gradual Increase in Regulatory Authority
Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation; United States of America; United Kingdom; Germany; Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of Pharmacovigilance; 3: Legal Basis: European Union; Introduction; Reorganization of the European Union Regulatory System Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management; Reporting Requirements; Transparency and Communication; Pharmacovigilance Enforcement; Further Information about Proposed New Legislation and Guidelines; 4: Ethical Oversight, Consent, and Confidentiality; Introduction; Practical Implications of Ethical Oversight; The Privacy and Security of Health Data; The Linkage of Electronic Health Data; The Conduct of Scientifically Sound Studies; Ethical Oversight and Privacy Law and Resulting Dilemmas; The Common Rule State LawsThe Health Insurance Portability and Accountability Act; Dilemmas Arising from the Health Insurance Portability and Accountability Act; Directions for Future Ethical Oversight and Privacy Provisions; References; 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1; Introduction; The International Conference on Harmonisation Step Process; ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations; ICH Step 2: Confirmation of Six Party Consensus; ICH Step 3: Regulatory Consultation ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations; Pharmacovigilance-Related International Conference on Harmonisation Topics; Topic ICH-E2A: Clinical Safety Data Management - Definitions and Standards for Expedited Reporting; ICH-E2D Topic: Post-Approval Safety Management - Definitions and Standards for Expedited Reporting; ICH-E2B Topic: Clinical Safety Data Management - Data Elements for Transmission of Individual Case Safety Reports ICH-E2C Topic: Clinical Safety Data Management - Periodic Benefit-Risk Evaluation Report (PBRER) |
| Record Nr. | UNINA-9910139125403321 |
| Chichester, England : , : Wiley Blackwell, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design
| Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design |
| Edizione | [Third edition.] |
| Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
| Descrizione fisica | 1 online resource (876 p.) |
| Disciplina | 363.19/463 |
| Soggetto topico |
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions Internationality Pharmacoepidemiology Product Surveillance, Postmarketing |
| ISBN |
1-118-82018-5
1-118-82014-2 1-118-82017-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Title page; Copyright page; Contents; Contributors; Foreword; 1: Introduction: Updated from Second Edition; Background; Diagnosing Adverse Drug Reactions; Current Methods of Pharmacovigilance; Hypothesis-Generating Methods; Spontaneous Adverse Drug Reaction Reporting; Prescription-Event Monitoring; Other Hypothesis-Generating Methods; Hypothesis-Testing Methods; Conclusion; References; 2: History of Pharmacovigilance; Early History of Drug Safety; Recent History; Pre-1962; Turning Point: The Federal Food, Drug and Cosmetics Act; Gradual Increase in Regulatory Authority
Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation; United States of America; United Kingdom; Germany; Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of Pharmacovigilance; 3: Legal Basis: European Union; Introduction; Reorganization of the European Union Regulatory System Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management; Reporting Requirements; Transparency and Communication; Pharmacovigilance Enforcement; Further Information about Proposed New Legislation and Guidelines; 4: Ethical Oversight, Consent, and Confidentiality; Introduction; Practical Implications of Ethical Oversight; The Privacy and Security of Health Data; The Linkage of Electronic Health Data; The Conduct of Scientifically Sound Studies; Ethical Oversight and Privacy Law and Resulting Dilemmas; The Common Rule State LawsThe Health Insurance Portability and Accountability Act; Dilemmas Arising from the Health Insurance Portability and Accountability Act; Directions for Future Ethical Oversight and Privacy Provisions; References; 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1; Introduction; The International Conference on Harmonisation Step Process; ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations; ICH Step 2: Confirmation of Six Party Consensus; ICH Step 3: Regulatory Consultation ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations; Pharmacovigilance-Related International Conference on Harmonisation Topics; Topic ICH-E2A: Clinical Safety Data Management - Definitions and Standards for Expedited Reporting; ICH-E2D Topic: Post-Approval Safety Management - Definitions and Standards for Expedited Reporting; ICH-E2B Topic: Clinical Safety Data Management - Data Elements for Transmission of Individual Case Safety Reports ICH-E2C Topic: Clinical Safety Data Management - Periodic Benefit-Risk Evaluation Report (PBRER) |
| Record Nr. | UNINA-9910813194203321 |
| Chichester, England : , : Wiley Blackwell, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmacoepidemiology and drug safety
| Pharmacoepidemiology and drug safety |
| Pubbl/distr/stampa | [Chichester] : , : John Wiley & Sons, , 1992- |
| Descrizione fisica | 1 online resource |
| Disciplina | 615 |
| Soggetto topico |
Drug Utilization
Drug-Related Side Effects and Adverse Reactions Epidemiologic Methods Epidemiology Pharmacology, Clinical Product Surveillance, Postmarketing |
| ISSN | 1099-1557 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910144034803321 |
| [Chichester] : , : John Wiley & Sons, , 1992- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmacoepidemiology and drug safety
| Pharmacoepidemiology and drug safety |
| Pubbl/distr/stampa | [Chichester] : , : John Wiley & Sons, , 1992- |
| Descrizione fisica | 1 online resource |
| Disciplina | 615 |
| Soggetto topico |
Drug Utilization
Drug-Related Side Effects and Adverse Reactions Epidemiologic Methods Epidemiology Pharmacology, Clinical Product Surveillance, Postmarketing |
| ISSN | 1099-1557 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996198638203316 |
| [Chichester] : , : John Wiley & Sons, , 1992- | ||
| 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 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 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. | UNINA-9910139903203321 |
| Geneva, : World Health Organization, 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
