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The following is a list of all entries tagged with recombinant:
Drug Regulators Publish Draft Guidance on Biosimilars for Recombinant Erthropoietins
Filed in Uncategorized, October 27, 2009, 10:59 amThis guideline lays down the non-clinical and clinical requirements for erythropoietin containing medicinal products claiming to be similar to another one already marketed.
Drug Regulators Publish Draft Guidance on Development of Similar Recombinant Erythroproetins Containing Prodcuts
Filed in clinical,pre-clinical,regulatory, October 20, 2009, 3:07 pmDrug Regulators EMEA publish Guidance on the Development of Similar Biological Products Containing Erythropoietins. Full Guidance Here. This guideline lays down the non-clinical and clinical requirements for erythropoietin containing medicinal products claiming to be similar to another one already marketed. The non-clinical section addresses the pharmaco-toxicological assessment and the clinical section the requirements for pharmacokinetic, [...]
Drug Regulators Publish Reflection Paper – Development of Similar Interferon Alfa
Filed in clinical,pre-clinical,regulatory, July 17, 2009, 9:28 amThe EMEA, published a reflection paper on the Non-Clinical and Clinical Development of Similar MEdicinical Products Containing Recombinant Interferon Alfa. in 2007, and has re-published the document on their website again.
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