Detection of New Adverse Drug Reactions
4th Edition
Published on 30. September 1998
Book
Hardback
416 pages
978-0-333-69391-9 (ISBN)
Description
This text examines the methods needed to analyze new adverse drug reactions, both inside and outside pharmaceutical companies. It evaluates the drug information cycle within pharmaceutical companies, which incorporates feedback about the drug from clinical trials (pre-marketing), epidemiological studies (pre- and post-marketing), and adverse event feedback (from doctors and drug information centres), an ongoing process known as "Pharmacovigilance". The information is then analyzed and collated prior to feeding the results back into the medical community and the drug development cycle. The book assesses existing methods of collection, storage and processing of adverse event data, and outlines ways of improving the drug information cycle. The fourth edition contains new chapters on: legal aspects; statistical methods; pharmacoepidemiology; quality of life; pharmacovigilance centres; mechanisms of ADRs; interactions and pharmacogenetics; and causality and signal recognition.
More details
Edition
4th Revised edition
Language
English
Place of publication
London
United Kingdom
Target group
College/higher education
Professional and scholarly
Edition type
Revised edition
Dimensions
Height: 340 mm
Width: 205 mm
Weight
1414 gr
ISBN-13
978-0-333-69391-9 (9780333693919)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Classification
Other editions
Previous edition
M. D. B. Stephens
The Detection of New Adverse Drug Reactions
Book
12/1992
3rd Edition
Macmillan
€88.52
Article exhausted; check for reprint
Persons
Content
Foreword - Preface to the Fourth Edition - Acknowledgements - Introduction; M.D.B. Stephens - Adverse Drug Reactions and Interactions: Mechanisms, Risk Factors, Management and Avoidance; P. Routledge - Toxicology for Adverse Drug Reactions; A. Dayan - The Methodology of the Collection of Adverse Event Data in Clinical Trials; M.D.B. Stephens - Quality of Life and Drug Therapy; G.Recchia and G. Di Carli - Laboratory Investigations; M.D.B. Stephens - The Pre-marketing Establishment of the Side-effect Profile of a New Drug; M.D.B. Stephens - Pharmacoepidemiology in the Pharmaceutical Industry; H. Tilson, - Statistics for Safety Data; C. Chuang-Stein - The Management of Adverse Drug Reaction and Adverse Event Data through Collection, Storage and Retrieval; V. Pinkerton and E. Swain, - Causality Assessment and Signal Recognition; M.D.B. Stephens - Pharmacovigilance Centres; B. Bigaud and N. Moore - Pharmacovigilance Regulations, Guidelines and ICH; J.C.C. Talbot - Legal Aspects of Pharmacovigilance; C. Bendell - Ethics, Honesty and Pharmacovigilance; M.D.B. Stephens - Abbreviations - Websites - Bibliography - Appendix - Drug Withdrawals - ADR - Times to Onset - UK Databases - Forms - SAMM Guidelines - References