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微生物发酵来源化学创新药申请上市药学研究的一般考虑 被引量：2

General considerations on the chemistry,manufacturing,and control research of fermented new drugs for market authorization
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摘要 微生物发酵来源化学创新药的生产工艺复杂,质量控制难度较大。本文参考国内外已发布的化学药品药学研究技术要求,围绕微生物发酵来源化学创新药的质量控制特点,探讨该类药物生产工艺、结构确证、质量标准等研究的一般考虑,为该类药物的研究提供参考。 The manufacturing process of fermented new drugs is complicated,and the quality control is difficult.Referring to the relevant technical guidances of new drug chemistry,manufacturing,and control research,centering on the quality control characteristics of fermented new drugs,this article discusses the general considerations on the manufacturing process,elucidation of structure,specification research,to provide a reference for the research of fermented new drugs.
作者 赵一飞 刘宗英 ZHAO Yi-fei;LIU Zong-ying(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
机构地区 国家药品监督管理局药品审评中心
出处 《中国新药杂志》 CAS CSCD 北大核心 2023年第2期159-162,共4页 Chinese Journal of New Drugs
关键词 微生物发酵 创新药 工艺研究 质量标准 fermentation new drugs process development specification
分类号 R95 [医药卫生—药学]
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中国新药杂志
2023年 第2期

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