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The most important part of a medicine as far as its weight is concerned, is constituted by its excipients, which have the important functions of guaranteeing the dosage, stability and bioavailability of the active principle. (...) Toxicological evaluation (...) (a) intrinsic toxicity, or adverse effects that may be encountered in the whole population; and (b) specific toxicity, which manifests only in people who are carriers of a transmissible disease or who are genetically predisposed, such as people with allergies and intolerances. The safety of pharmaceutical excipients (304 Ko - pdf)
Il Farmaco (2003) 58:541-550
Giorgio Pifferi, Patrizia Restani

Innovation and placebos in research : a new design of clinical trial (62 Ko - pdf)
The Lancet (2003) 362: 2036-7 [December 20/27]
Anne Holbrook, Charles Goldsmith

The placebo standard in regulatory market approval : why the declaration of Helsinki has been ignored for 35 years (22 Ko - pdf)
McGill Journal of Medicine (2001) 6: 52-55 
Patrick James Villeneuve

Comment prévenir le risque thérapeutique médicamenteux (62 Ko - pdf)
Rev Med Interne (2001) 22:1237-43
Gilles Bouvenot

The proposed guidelines for the safety evaluation of new excipients (919 Ko - pdf)
European Pharmaceutical Review - Novembre 1997
IPEC European safety committee 

Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals, their efficacy and safety in elderly people is not fully established. (...) New cancer diagnoses were more frequent on pravastatin than on placebo (1·25, 1·04–1·51, p=0·020). However... Pravastatin in elderly individuals at risk of vascular disease (PROSPER) : 
a randomised controlled trial (107 Ko - pdf)
The Lancet (2002) 360: 1623-1630 
James Shepherd, Gerard J Blauw, Michael B Murphy, Edward L E M Bollen, Brendan M Buckley, Stuart M Cobbe, Ian Ford, Allan Gaw, Michael Hyland, J Wouter Jukema, Adriaan M Kamper, Peter W Macfarlane, A Edo Meinders, John Norrie, Chris J Packard, Ivan J Perry, David J Stott, Brian J Sweeney, Cillian Twomey, Rudi G J Westendorp, on behalf of the PROSPER study group

 

création le 24 janvier 2003
dernière modification le 11 juillet 2005

 

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