Healthy Skepticism Library item: 11978

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Publication type: Journal Article

Lamarque V, Pletan Y.
[The Pharmaceutical Industry and the adverse effects of the drugs].
Ann Pharm Fr 2007 Sep; 65:(5):308-14
http://www.masson.fr/masson/portal/bookmark?Global=1&Page=18&MenuIdSelected=106&MenuItemSelected=0&MenuSupportSelected=0&CodeProduct4=260&CodeRevue4=APF&Path=REVUE/APF/2007/65/5/ARTICLE11942567985.xml&Locations=

Abstract:

New drug development is a long, expensive and hazardous process especially regarding the final outcome. During the first non-clinical steps, molecules identified as potential candidates are screened for their toxicological profile, which allows to eliminate some but also to identify possible “target” organs. Then clinical trials are conducted, where tolerance profile knowledge is increased through the development with the detection of the most frequent adverse effects (between 1% and 1 per thousand). At marketing authorization, because of the limited number and of the selectivity of patients enrolled in clinical trials, the drug safety profile is based on the more frequent adverse effects. In Europe, since November 2005, a new regulation – the Risk Management system – has been added to Pharmacovigilance. These are designed to better anticipate and even minimize important identified or potential risks or to better inform on populations not studied during the clinical trials. This concept is based on risk reduction throughout drug’s life cycle with specific strategic actions in addition to the product information, in order to optimise the drug benefit/risk ratio. Pharmaceutical companies will therefore invest significantly in post-marketing, allowing proper and safety use of their products. As they played a major role in the clinical development few years ago, they could from now on, be recognised as the key player towards this new paradigm defined as the post-approval development.

Keywords:
Prevent, Risk management plan, Risk minimization plan, Post-approval development PMID: 17982378 [PubMed - in process]

Notes:

[Article in French]