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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。
This article reviews the role and limitations of bioassays in the quality control of recombinant human follicle stimulating hormone (rhFSH). For long-run between consistent rhFSH products, physical and chemical determination will replace the determination of biological potency, but in the development phase still need to select bioassay.