Clinical trial analysis of Medway——a recombinant human serum albumin
Recombinant human albumin can reduce the risk of viral contamination of blood-derived biological products,and alleviate the problem of limited human plasma sources.At present,several domestic and foreign companies are involved in the research and development of pharmaceutical injection grade recombinant human albumin.There are recombinant human albumin entering the clinical trial stage in China,but only a Japanese production of recombinant human albumin(trade name:Medway)has been approved.In order to provide reference for the clinical trial development of recombinant human albumin under investigation in China,the clinical trial content of Medway,and the basic considerations on overall clinical study strategy,dosing regimen,bioequivalence analyses,efficacy analyses,safety analyses,and so on,are introduced and analyzed briefly in this article.
recombinant human serum albuminefficacy analysessafety analyses
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