关于发布化学药物稳定性研究等16个技术指导原则的通知
关于发布化学药物稳定性研究等16个技术指导原则的通知
国食药监注[2005]106号
2005年03月18日 发布
各省、自治区、直辖市食品药品监督管理局（药品监督管理局）：
为促进我国药品的研究开发，指导药物研究单位用科学规范的方法开展药品研究工作，我局自2003年5月开始正式启动了化学药物研究技术指导原则的起草和修订工作。指导原则的修订是以《中华人民共和国药品管理法》和《药品注册管理办法》为依据，以科学性、前瞻性、可操作性为指导思想，充分借鉴了ICH等技术指导原则。目前我局已制定了化学药物稳定性等16个研究技术指导原则（见附件），现予发布，请参照执行。
附件：1．化学药物稳定性研究技术指导原则
2．化学药物原料药制备和结构确证研究的技术指导原则
3．化学药物杂质研究的技术指导原则
4．化学药物制剂研究基本技术指导原则
5．化学药物质量控制分析方法验证技术指导原则
6．化学药物残留溶剂研究的技术指导原则
7．化学药物临床药代动力学研究技术指导原则
8．化学药物制剂人体生物利用度和生物等效性研究技术指导原则
9．化学药物临床试验报告的结构与内容技术指导原则
10．化学药物和生物制品临床试验的生物统计学技术指导原则
11．化学药物急性毒性试验技术指导原则
12．化学药物长期毒性试验技术指导原则
13．化学药物一般药理学研究技术指导原则
14．化学药物刺激性、过敏性和溶血性研究技术指导原则
15．化学药物非临床药代动力学研究技术指导原则
16．化学药物质量标准建立的规范化过程技术指导原则
国家食品药品监督管理局
二零零五年三月十八日
相关链接：http://www.sfda.gov.cn/WS01/CL0844/10368.html
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