Mann's pharmacovigilance / (Record no. 13234)
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| fixed length control field | 07181cam a2201021 i 4500 |
| 001 - CONTROL NUMBER | |
| control field | ocn868511726 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20171224114524.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION | |
| fixed length control field | m o d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr ||||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 140117s2014 enk ob 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER | |
| LC control number | 2014002242 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | DLC |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | DLC |
| Modifying agency | YDX |
| -- | MHW |
| -- | N$T |
| -- | DG1 |
| -- | CUS |
| -- | UKMGB |
| -- | YDXCP |
| -- | OCLCF |
| -- | NLGGC |
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| -- | CDX |
| -- | EBLCP |
| -- | DEBSZ |
| -- | COO |
| -- | OCLCQ |
| -- | OCLCO |
| -- | LOA |
| -- | DG1 |
| 016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER | |
| Record control number | 016697425 |
| Source | Uk |
| 019 ## - | |
| -- | 875820397 |
| -- | 878148990 |
| -- | 960202546 |
| -- | 961516735 |
| -- | 962726974 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781118820148 |
| Qualifying information | (ePub) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1118820142 |
| Qualifying information | (ePub) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781118820179 |
| Qualifying information | (Adobe PDF) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1118820177 |
| Qualifying information | (Adobe PDF) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781118820186 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1118820185 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 0470671041 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780470671047 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 9780470671047 |
| Qualifying information | (cloth) |
| 029 1# - (OCLC) | |
| OCLC library identifier | DEBSZ |
| System control number | 431662967 |
| 029 1# - (OCLC) | |
| OCLC library identifier | GBVCP |
| System control number | 813902444 |
| 029 1# - (OCLC) | |
| OCLC library identifier | NZ1 |
| System control number | 15624996 |
| 029 1# - (OCLC) | |
| OCLC library identifier | NZ1 |
| System control number | 15920442 |
| 029 1# - (OCLC) | |
| OCLC library identifier | AU@ |
| System control number | 000052429159 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)868511726 |
| Canceled/invalid control number | (OCoLC)875820397 |
| -- | (OCoLC)878148990 |
| -- | (OCoLC)960202546 |
| -- | (OCoLC)961516735 |
| -- | (OCoLC)962726974 |
| 042 ## - AUTHENTICATION CODE | |
| Authentication code | pcc |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RM302.5 |
| 060 10 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | QV 771 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | BUS |
| Subject category code subdivision | 032000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | SOC |
| Subject category code subdivision | 000000 |
| Source | bisacsh |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 363.19/463 |
| Edition number | 23 |
| 049 ## - LOCAL HOLDINGS (OCLC) | |
| Holding library | MAIN |
| 130 0# - MAIN ENTRY--UNIFORM TITLE | |
| Uniform title | Pharmacovigliance. |
| 245 10 - TITLE STATEMENT | |
| Title | Mann's pharmacovigilance / |
| Statement of responsibility, etc | edited by Elizabeth B. Andrews, Nicholas Moore. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | Third edition. |
| 264 #1 - | |
| -- | Chichester, West Sussex, UK ; |
| -- | Hoboken, NJ : |
| -- | Wiley Blackwell, |
| -- | 2014. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource. |
| 336 ## - | |
| -- | text |
| -- | txt |
| -- | rdacontent |
| 337 ## - | |
| -- | computer |
| -- | c |
| -- | rdamedia |
| 338 ## - | |
| -- | online resource |
| -- | cr |
| -- | rdacarrier |
| 500 ## - GENERAL NOTE | |
| General note | Preceded by Pharmacovigilance / editors, Ronald D. Mann, Elizabeth B. Andrews. 2nd ed. c2007. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 588 0# - | |
| -- | Print version record and CIP data provided by publisher. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc | Mann's Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | ICH-E2C Topic: Clinical Safety Data Management -- Periodic Benefit-Risk Evaluation Report (PBRER). |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacovigilance. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug-Related Side Effects and Adverse Reactions |
| Form subdivision | classification. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Internationality. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacoepidemiology |
| Form subdivision | Methods. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Product Surveillance, Postmarketing. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacovigilance. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug-Related Side Effects and Adverse Reactions |
| General subdivision | classification. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Internationality. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacoepidemiology |
| General subdivision | methods. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Product Surveillance, Postmarketing. |
| 650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug-Related Side Effects and Adverse Reactions |
| General subdivision | classification. |
| 650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Internationality. |
| 650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacoepidemiology |
| General subdivision | methods. |
| 650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacovigilance. |
| 650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Product Surveillance, Postmarketing. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | BUSINESS & ECONOMICS |
| General subdivision | Infrastructure. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | SOCIAL SCIENCE |
| General subdivision | General. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacoepidemiology. |
| Source of heading or term | fast |
| -- | (OCoLC)fst01060242 |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 655 #0 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Andrews, Elizabeth B., |
| Relator term | editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Moore, Nicholas, |
| Relator term | editor. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Display text | Print version: |
| Edition | Third edition. |
| Place, publisher, and date of publication | Chichester, West Sussex, UK : John Wiley & Sons Inc., 2014 |
| International Standard Book Number | 9780470671047 |
| Record control number | (DLC) 2014000062 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | http://onlinelibrary.wiley.com/book/10.1002/9781118820186 |
| Public note | Wiley Online Library |
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