Talbot / Waller Stephens' Detection of New Adverse Drug Reactions

5. Auflage 2004
ISBN: 978-0-470-09265-1
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 762 Seiten, E-Book

A key text for all those involved in pharmacovigilance.
Detection of new adverse drug reactions is fundamental to theprotection of patients from harm that may occur as a result ofmedication. This book explores the methods used to investigate newadverse drug reactions, discussing all elements from the scientificbackground and animal toxicology through to worldwide regulatoryand ethical issues.
Stephens' Detection of New Adverse Drug Reactionsprovides comprehensive and up-to-date coverage of materialfundamentally important to all those active in the field, whetherthey work in the pharmaceutical industry, drug regulatoryauthorities or in academia.
The fifth edition of this classic reference work includes newchapters on:
* vaccine safety surveillance
* managing drug safety issues with marketed products
* operational aspects of drug safety function
* safety of biotechnology products
* future of pharmacovigilance
Reviews of previous editions:
"This book surpasses all its educational aims. Not only isthe subject matter covered comprehensively but the material ispresented in a very user-friendly manner. The editors havesucceeded in producing a highly-specific, definitive reference bookwhich doubles as a most enjoyable read."
--Commended by the 1999 BMA Medical BookCompetition
"For anyone entering the field of adverse reaction monitoringone could not wish for a better primer"
--International Journal of Risk and Safety inMedicine

Autoren/Hrsg.

Talbot, John

Waller, Patrick

Inhaltsverzeichnis

Foreword.
Preface.
List of Contributors.
1. Introduction (M. Stephens).
2. Adverse Drug Reaction and Interactions: Mechanisms, RiskFactors, Detection, Management and Prevention (P. Routledge).
3. Toxicology and Adverse Drug Reactions (D. Snodin).
4. Clinical Trials: Collection of Safety Data and Establishingthe Adverse Drug Reaction Profile (J. Talbot & M.Stephens).
5. Clinical Laboratory Safety Data in Drug Studies (A.Craig).
6. Statistics: Analysis and Presentation of Safety Data (S.Evans).
7. Causality and Correlation in Pharmacovigilance (S.Shakir).
8. Managing Drug Safety Issues with Marketed Products (P.Waller & H. Tilson).
9. Regulatory Aspects of Pharmacovigilance (B. Arnold).
10. Legal Aspects of Pharmacovigilance (C. Bendall).
11. Operational Aspects of the Drug Safety Function within aPharmaceutical Company (J. Steiner).
12. Dictionaries and Coding in Pharmacovigilance (E. Brown).
13. Safety of Biotechnology Products (B. Brown and M.Westland).
14. Vaccine Safety Surveillance (E. Miller).
15. Ethical Issues in Drug Safety (M. Stephens).
16. A Model for the Future Conduct of Pharmacovigilance (P.Waller and S. Evans).
Appendix I.
Appendix II.
Bibliography.
Index.