LIBRARY CATALOGUE

Pharmacovigilance : (Record no. 1961)

MARC details
000 -LEADER
fixed length control field 04569cam a2200505 i 4500
001 - CONTROL NUMBER
control field 22132886
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20250823191646.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 210714s2019 mouab b 001 0 eng c
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
LC control number 2021301538
016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER
Record control number 101738270
Source DNLM
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9780323581165
Qualifying information pbk.
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 0323581161
Qualifying information pbk.
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)on1015855399
040 ## - CATALOGING SOURCE
Original cataloging agency NLM
Language of cataloging eng
Transcribing agency NLM
Description conventions rda
Modifying agency YDX
-- OCLCF
-- OCLCO
-- OCLCA
-- DLC
042 ## - AUTHENTICATION CODE
Authentication code pcc
050 00 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RM302.5
Item number .D63 2019
060 00 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER
Classification number 2018 I-615
060 10 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER
Classification number QV 771
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Doan, Thao,
Relator term author.
245 10 - TITLE STATEMENT
Title Pharmacovigilance :
Remainder of title a practical approach /
Statement of responsibility, etc. Thao Doan, Cheryl Renz, Mondira Bhattacharya, Fabio Lievano, Linda Scarazzini.
264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Place of production, publication, distribution, manufacture St. Louis, Missouri :
Name of producer, publisher, distributor, manufacturer Elsevier,
Date of production, publication, distribution, manufacture, or copyright notice [2019]
300 ## - PHYSICAL DESCRIPTION
Extent xiv, 213 pages :
Other physical details color illustrations, color maps ;
Dimensions 24 cm
336 ## - CONTENT TYPE
Content type term text
Content type code txt
Source rdacontent
337 ## - MEDIA TYPE
Media type term unmediated
Media type code n
Source rdamedia
338 ## - CARRIER TYPE
Carrier type term volume
Carrier type code nc
Source rdacarrier
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Front Cover; Pharmacovigilance: A Practical Approach; Pharmacovigilance: A Practical Approach; Copyright; List of Contributors; Acknowledgments; Introduction; Contents; I -- THE REGULATORY ENVIRONMENT; 1 -- Does Regulation Drive Science or Does Science Drive Regulation?; INTRODUCTION; IMPORTANT EVENTS IN PHARMACOVIGILANCE; IMPORTANT PHARMACOVIGILANCE ORGANIZATIONS; IMPORTANT REGULATORY AUTHORITIES AND REGIONS; THE WORLD OF REGULATORY SCIENCE; EMA PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE; NEW WAVE OF GLOBAL PHARMACOVIGILANCE REGULATION; THE EU QPPV; THE RISE OF THE NATIONAL QPPV
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note The Pharmacovigilance System Master FileIs Regulatory Guidance Just Guidance?; How can Industry Influence Regulation?; Enforcement of Pharmacovigilance Regulations; CONCLUSIONS; REFERENCES; II -- SAFETY DATA AND REAL WORLD EVIDENCE; 2 -- Signal Management and Methods of Signal Detection; INTRODUCTION; SIGNALS (BOX 2.2); SIGNAL DETECTION; SIGNAL VALIDATION; SIGNAL ASSESSMENT; DETERMINING BENEFIT/RISK (BOX 2.5); SAFETY GOVERNANCE IN PHARMACOVIGILANCE; SAFETY GOVERNANCE FRAMEWORK; SAFETY OVERSIGHT BOARD (BOX 2.8); SAFETY MANAGEMENT TEAMS 18; FIRST-IN-HUMAN REVIEW COMMITTEE 19,20
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note INTERNAL SAFETY ADVISORY GROUPS SAFETY ASSESSMENT COMMITTEES 21; SAFETY GOVERNANCE SUPPORT; SAFETY GOVERNANCE PROCESS (BOX 2.11); CONCLUSION; LIST OF DEFINITIONS; REFERENCES; FURTHER READING; 3 -- Product Safety Monitoring in Clinical Trials; INTRODUCTION; SAFETY PLANNING; Systemic Approach; Development Risk Management Plan and Development Core Safety Information (Box 3.3); Specific Safety Issues (Box 3.4); DATA COLLECTION AND EVALUATION; Data Collection (Box 3.5); General principles and considerations; Specialized data collection and adjudication; Baseline risk factor documentation
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note Safety topics of interest Event adjudication; Data monitoring committee (Box 3.6); Safety assessment committees; Data Evaluation; Quantitative analysis; Individual studies (Box 3.8); Individual studies (Box 3.8); Meta-Analysis (Box 3.11); Meta-Analysis (Box 3.11); Qualitative analysis (Box 3.12); Signal evaluation; Safety actions in response to a confirmed signal-risk management (Box 3.13); REPORTING AND COMMUNICATION OF SAFETY INFORMATION; Expedited Reporting; Causality assessment of individual case safety report (Box 3.14); Communicating Safety Information (Box 3.16); Informed consent
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note Investigator brochure Development Safety Update Report; CONCLUSION; REFERENCES; 4 -- Causality Assessment and Examples of Adverse Drug Reactions (Drug-Induced Liver Injury, Renal, Skin, and Major ...; INTRODUCTION; THE CIOMS WORKING GROUP CRITERIA; THE BRADFORD-HILL CRITERIA; LIVER: CAUSALITY ASSESSMENT IN DRUG-INDUCED LIVER INJURY IN ADULTS; Step 1: Take History and Perform a Physical Examination; Step 2: Calculate the R-Value; Step 3: Exclude Differential Diagnoses; Step 4: Literature Review; Step 5: Clinical Judgement for Final Drug-Induced Liver Injury Diagnosis
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pharmacovigilance.
650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pharmacovigilance.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drug Monitoring.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Patient Safety.
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pharmacovigilance.
Source of heading or term fast
Authority record control number or standard number (OCoLC)fst02002642
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Renz, Cheryl,
Relator term author.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Bhattacharya, Mondira,
Titles and other words associated with a name MD,
Relator term author.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Lievano, Fabio,
Relator term author.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Scarazzini, Linda,
Relator term author.
906 ## - LOCAL DATA ELEMENT F, LDF (RLIN)
a 7
b cbc
c pccadap
d 2
e ncip
f 20
g y-gencatlg
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Library of Congress Classification
Koha item type Books
Suppress in OPAC No
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Shelving location Date acquired Total checkouts Full call number Barcode Date last seen Price effective from Koha item type
    Library of Congress Classification     2nd Floor Main Library 2nd Floor Main Library General stacks 06/17/2025   RM302.5 .D63 2019 101863 06/17/2025 06/17/2025 Books