Mann's pharmacovigilance / (Record no. 21105)

MARC details
000 -LEADER
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001 - CONTROL NUMBER
control field ocn868511726
003 - CONTROL NUMBER IDENTIFIER
control field OCoLC
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20230823095501.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION
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007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
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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
-- E7B
-- 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
ISBN 9781118820148
Qualifying information (ePub)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 1118820142
Qualifying information (ePub)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781118820179
Qualifying information (Adobe PDF)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 1118820177
Qualifying information (Adobe PDF)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781118820186
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 1118820185
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 0470671041
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 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).
526 ## - STUDY PROGRAM INFORMATION NOTE
Department Media and Communication
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 <a href="http://dx.doi.org/10.1002/9781118820186">http://dx.doi.org/10.1002/9781118820186</a>
Public note Wiley Online Library
994 ## -
-- 92
-- DG1

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