Literature DB >> 15976815

Monitoring the safety of licensed medicines.

Alasdair Breckenridge1, Kent Woods, June Raine.   

Abstract

The withdrawal of the selective cyclooxygenase 2 inhibitor rofecoxib owing to cardiovascular side effects ignited debate about the need for major changes to current mechanisms for post-marketing surveillance (PMS) of drug safety. Here, we discuss the current mechanisms, whether they are being used appropriately, and consider the need for changes to regulatory systems.

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Year:  2005        PMID: 15976815     DOI: 10.1038/nrd1778

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN: 1474-1776            Impact factor:   84.694


  3 in total

Review 1.  Beyond debacle and debate: developing solutions in drug safety.

Authors:  Amrit Ray
Journal:  Nat Rev Drug Discov       Date:  2009-09-18       Impact factor: 84.694

2.  Number of patients studied prior to approval of new medicines: a database analysis.

Authors:  Ruben G Duijnhoven; Sabine M J M Straus; June M Raine; Anthonius de Boer; Arno W Hoes; Marie L De Bruin
Journal:  PLoS Med       Date:  2013-03-19       Impact factor: 11.069

3.  Integrating Multiple Evidence Sources to Predict Adverse Drug Reactions Based on a Systems Pharmacology Model.

Authors:  D-S Cao; N Xiao; Y-J Li; W-B Zeng; Y-Z Liang; A-P Lu; Q-S Xu; A F Chen
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2015-09-11
  3 in total

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