重组人促卵泡激素质量控制中理化测定代替生物测定简介
Physicochemical methods alternative for bioassays for recombinant human follicle-stimulating hormone in quality control
分类号：
出版年·卷·期（页码）：2014,34 (9):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
本文综述重组人促卵泡激素(rhFSH)质量控制中的生物测定的作用与局限性。对长期批次间一致的rhFSH产品，理化测定将代替生物效价的测定，但在研发阶段仍需选择生物测定。
-----英文摘要：---------------------------------------------------------------------------------------
Limitations and role of the bioassay for recombinant human follicle-stimulating hormone(rhFSH)were reviewed.It is clarified that the physicochemical determination will substitute the potency determination for rhFSH preparations which have long term batch-to-batch consistency while bioassay would still be chosen in the research and development stage.
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