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2016年12月美国FDA发布了《工业界植物药研发指南》最新定稿版,通过对美国FDA植物药指南新旧版本的对比发现,尽管FDA认同植物药传统应用经验的历史事实,并在早期临床研究中给予了“宽进”政策,但随着研发的深入,强调了全程质量控制、临床受试样品和原料与上市产品及其原料在质量和疗效上的一致性,保障终产品的“严出”。指南推荐了一批新的方法和思路,如从药材到成品质量控制的“证据链完整性法”、生物测定法、质量平衡法、多批次临床研究设计、剂量-响应效应等技术要求,以确保临床研究用原料、受试样品与拟上市用原料、成品的质量一致性,进而保障疗效的一致性;在监管上同时要求药材的GACP和中间体与成品的cGMP。
In December 2016, the United States FDA released the latest version of the Guidebook for R & D of Industrial Botanical Drugs. By comparing the new and old versions of the FDA Guide to Botanical Medicines in the United States, the FDA found that although the FDA recognized the historical facts about the traditional application experience of botanical drugs, In the “R & D” policy, but with the deepening of research and development, emphasizing the entire quality control, clinical trial samples and raw materials and listed products and their raw materials in the quality and efficacy of consistency, the protection of the final product “Strict out ”. The guidelines recommend a number of new methods and ideas, such as the “evidence chain integrity method” from medicinal materials to finished product quality control, bioassays, mass balance methods, multi-batch clinical study design, and dose-response effects Requirements to ensure that the quality of clinical research with the raw materials, test samples and to be listed with the raw materials, finished product consistency, and to ensure the consistency of efficacy; regulatory requirements both GACP and intermediates and finished cGMP.