Reference : Recommendations for an update of 2003 European regulatory requirements for registrati...
Scientific journals : Article
Human health sciences : General & internal medicine
http://hdl.handle.net/2268/87058
Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.
English
Smolen, Josef S. [> > > >]
Boers, Maarten [> > > >]
Abadie, Eric [> > > >]
Breedveld, Ferdinand C. [> > > >]
Emery, Paul [> > > >]
Bardin, Thomas [> > > >]
Goel, Niti [> > > >]
Ethgen, Dominique J. [> > > >]
Avouac, Bernard P. [> > > >]
Dere, Willard H. [> > > >]
Durez, Patrick [> > > >]
Matucci-Cerinic, Marco [> > > >]
Flamion, Bruno [> > > >]
Laslop, Andrea [> > > >]
Lekkerkerker, Frits J. [> > > >]
Miossec, Pierre [> > > >]
Mitlak, Bruce H. [> > > >]
Ormarsdottir, Sif [> > > >]
Paolozzi, Laurence [> > > >]
Rao, Ravi [> > > >]
Reiter, Susan [> > > >]
Tsouderos, Yannis [> > > >]
Reginster, Jean-Yves mailto [Université de Liège - ULg > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé >]
2011
Current Medical Research & Opinion
LibraPharm Ltd
27
2
315-25
Yes (verified by ORBi)
International
0300-7995
1473-4877
Newbury Berkshire
United Kingdom
[en] Since 2003, the European Medicines Agency (EMA) document, 'Points to consider on clinical investigation of medicinal products other than NSAIDs (nonsteroidal anti-inflammatory drugs) for the treatment of rheumatoid arthritis' has provided guidance for the clinical development of both biologic and non-biologic disease-modifying antirheumatic drugs (DMARDs). In the last few years, several new products have been developed or are in development for the treatment of RA, which offer significant efficacy with regard to disease control, including prevention of structural damage and disability. Concurrently, novel insights have been gained with respect to the assessment of disease activity, joint damage and disability. New treatment strategies have been established which relate to early therapy, tight control and rapid switching of medication. Accordingly, several new EULAR/ACR recommendations have been or are being developed. Several important additions and changes are needed in the 2003 guidance to incorporate the current scientific knowledge into clinical trial design for the development of future products. Under the auspices of the Group for the Respect of Ethics and Excellence in Science (GREES), a group of experts in the field of RA and clinical trial design met to provide a consensus recommendation for an update to the 2003 EMA guidance document.
http://hdl.handle.net/2268/87058
10.1185/03007995.2010.542135

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