L'épidémiologie des maladies rénales - Société de néphrologie

70 P. LANDAIS58. Ro n c o C. Is the advent of biosimilars affecting the practice of nephrology and the safety ofpatients ? Contrib Nephrol., 2008 ; 161 : 261-270.59. Ke i t h i-Re d d y SR, Ka n da s a m y S, Si n g h AK. Pure red cell aplasia due to follow-on epoetin.Kidney Int, 2008 ; 74 : 1617-1622.60. Eu ro p e a n c o m m is s io n En t e r p r i s e a n d In d u s t ry. « Guideline on risk management systemsfor medicinal products for human use EMEA/CHMP/96268/2005 » Eudralex Volume 9A –Pharmacovigilance for Medicinal Products for Human Use. Sept 2008. http ://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol9_en.htm61. Ioa n n i d i s JP, Eva n s SJ, Gø t z s c h e PC, et al. Better reporting of harms in randomized trials : anextension of the CONSORT statement. Ann Intern Med, 2004 ; 141 : 781-788.62. Lo k e YK, Pr i c e D, Herxheimer A ; Cochrane Adverse Effects Methods Group. Systematic reviewsof adverse effects : framework for a structured approach. BMC Med Res Methodol, 2007 ; 7 : 32.63. Pro p o s i t i o n s c o n s e n s u e l l e s d e l a s o c i é t é d e n é p h ro l o g i e, d e l a s o c i é t é f r a n c o p h o n e d ed i a ly s e e t d e l a s o c i é t é d e n é p h ro l o g i e p é d i at r i q u e. Règles d’utilisation des biosimilaires.Néphrol Thérap, 2006 ; 2 : 432-435.64. Co v i c A, Ca n nata-An d i a J, Ca n c a r i n i G et al. Biosimilars and biopharmaceuticals: whatthe nephrologists need to know – a position paper by the ERA-EDTA Council. Nephrol DialTransplant,2008 ; 23 : 3731-3737.65. EMEA Co m m i t t e e f o r Me d i c i na l Pro d u c t s f o r Hu m a n Use. Guidelines on similar biologicalmedicinal products containing biotechnology derived proteins as active substance: non-clinicaland clinical issues. London, 2006 : http://www.emear.eu.int/66. EMEA Co m m i t t e e f o r Me d i c i na l Pro d u c t s f o r Hu m a n Use. Guidelines on similar biologicalmedicinal products containing biotechnology derived proteins as active substance: quality issues.London, 2006. Available at : http://www.emear.eu.int/67. Eu ro p e a n Pu b l i c Assessment Rw e p o r t a n d Su m m a r y o f p ro d u c t Ch a r ac t e r i s t i c sEp o i e t i n a l fa He x a l. Date of issue of Marketing Authorisation valid throughout the EuropeanUnion : 28 August 2007. http ://www.emea.europa.eu/humandocs/Humans/EPAR/epoetinalfahexal/epoetinalfahexal.htm68. http ://clinicaltrials.gov/ct2/show/NCT00391287 ?cntry1=EU%3ALU&rank=23&show_desc=Y69. Sc h e l l e k e n s H. The first biosimilar epoetin : but how similar is it ? Clin J Am Soc Nephrol,2008 ; 3 : 174-178.70. Me s s i a e n C, Le Mi g n ot L, Rat h A, et al. CEMARA : a Web dynamic application within a N-tierarchitecture for rare diseases. Stud Health Technol Inform, 2008 ; 136 : 51-56.71. La n da i s P, Si m o n e t A, Gu i l l o n D, et al. SIMS REIN : un système d’information multisourcepour l’insuffisance rénale terminale. CR Biol, 2002 ; 325 (4) : 515-528.