摘要
重组技术生产的人血白蛋白可以降低血浆来源人血白蛋白的病毒污染风险,缓解人血浆来源受限等问题.目前,国内外有多家公司从事药用注射级重组人血白蛋白研发,我国已有重组人血白蛋白进入临床试验阶段,但只有日本批准了一个本国生产的重组人血白蛋白(商品名:Medway)上市.本文简要介绍了 Medway的临床试验内容,分析其总体临床试验策略、给药方案、生物等效性研究、有效性评价和安全性评价的基本考虑,以期为国内处于研发中的重组人血白蛋白的临床试验提供参考.
Abstract
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.
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