Cobert's manual of drug safety and pharmacovigilance / (Record no. 100651)

MARC details
000 -LEADER
fixed length control field 03670nam a22002777a 4500
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20261029103143.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 261029t2025 |||||||| |||| 00| 0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9789819800216
050 ## - LIBRARY OF CONGRESS CALL NUMBER
Classification number Allied RM 302.5
Item number C63 2025
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Cobert, Barton
245 10 - TITLE STATEMENT
Title Cobert's manual of drug safety and pharmacovigilance /
Statement of responsibility, etc. Barton Cobert, William W. Gregory, Jean-Loup Thomas, and Catherine Baldridge.
250 ## - EDITION STATEMENT
Edition statement 4th ed.
264 ## - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Place of production, publication, distribution, manufacture New Jersey :
Name of producer, publisher, distributor, manufacturer World Scientific,
Date of production, publication, distribution, manufacture, or copyright notice 2025.
300 ## - PHYSICAL DESCRIPTION
Extent xxxiv, 504 pages ;
Dimensions 28 cm
336 ## - CONTENT TYPE
Source rdacontent
Content type term text
337 ## - MEDIA TYPE
Source rdamedia
Media type term unmediated
338 ## - CARRIER TYPE
Source rdacarrier
Carrier type term volume
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note ch. 1. The history and theory of drug safety and pharmacovigilance. -- ch. 2. Primary definitions to safety & pharmacovigilance. -- ch. 3. Regulations, directives, guidance, laws and consensus documents. -- ch. 4. The United States Food and Drug Administration. -- ch. 5. The European Medicines Agency. -- ch. 6. Council for International Organizations of Medical Sciences (CIOMS). -- ch. 7. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). -- ch. 8. The Uppsala Monitoring Centre. -- ch. 9. Biopharmaceutical companies. -- ch. 10. The Safety Department's role in cross-functional areas. -- ch. 11. Organization of a typical drug safety department. -- ch. 12. Clinical trial phases and investigator-initiated trials. -- ch. 13. Data monitoring committees and investigational review boards/ethics committees. -- ch. 14. How an Individual Case Safety Report (ICSR) is handled from start to finish. -- ch. 15. Seriousness, expectedness, and causality. -- ch. 16. Coding of adverse events and drug names. -- ch. 17. Spontaneous post-marketing adverse events. -- ch. 18. Generics, excipients, placebos, and counterfeits. -- ch. 19. Artificial intelligence and pharmacovigilance. -- ch. 20. Expedited and aggregate reporting in clinical trials. -- ch. 21. Post-marketing spontaneous ICSR/SAE reporting. -- ch. 22. Post-marketing aggregate safety reporting. -- ch. 23. The mathematics of adverse events. -- ch. 24. Pharmacoepidemiology: its practical use in the world of drug safety. -- ch. 25. Signals and signaling in the context of risk management. -- ch. 26. Risk assessment, evaluation, management, mitigation, & strategy. -- ch. 27. Drug interactions. -- ch. 28. The many players in the world of pharmacovigilance. -- ch. 29. Pharmacovigilance system master file. -- ch. 30. The qualified (individual) person(s) responsible for pharmacovigilance. -- ch. 31. Product labeling. -- ch. 32. Business partners and exchange of safety data. -- ch. 33. Where data reside. -- ch. 34. Information technology and safety database. -- ch. 35. Data privacy and security. -- ch. 36. Children, elderly, and other special (vulnerable) groups. -- ch. 37. Acute and chronic (late occurring) adverse events, adverse events. -- ch. 38. Pregnancy and lactation. -- ch. 39. Product quality issues. -- ch. 40. Safety data volume, archival, record retention, and good documentation. -- ch. 41. PV quality system. -- ch. 42. Training. -- ch. 43. Audits and inspections. -- ch. 44. Ethical issues and conflicts of interests. -- ch. 45. Universities and academic medical centers. -- ch. 46. Vaccinovigilance. -- ch. 47. Real-world issues: case studies. -- ch. 48. Medical marijuana and pharmacovigilance.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drugs
Form subdivision Handbooks, manuals, etc
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Pharmacoepidemiology
Form subdivision Handbooks, manuals, etc
700 1# - ADDED ENTRY--PERSONAL NAME
Relator code author
Personal name Gregory, William W.
700 1# - ADDED ENTRY--PERSONAL NAME
Relator code author
Personal name Thomas, Jean-Loup
700 1# - ADDED ENTRY--PERSONAL NAME
Relator code author
Personal name Baldridge, Catherine
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Library of Congress Classification
Koha item type Books
Call number prefix EAC Cavite-Allied Health Sciences Section
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 Cost, normal purchase price Total Checkouts Full call number Barcode Date last seen Cost, replacement price Price effective from Koha item type
    Library of Congress Classification     EAC Library Cavite EAC Library Cavite EAC Cavite-Allied Health Sciences Section 07/27/2026 7956.00   Allied RM 302.5 C63 2025 ML19771 10/29/2026 7956.00 10/29/2026 Books