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中药、天然药物中试研究的技术指导原则
二ΟΟ五年三月
目录
一概述······················································································································································1
二、基本内容··········································································································································1
(一)中试研究的作用···············································································································1
(二)中试研究的有关问题····································································································1
1、规模与批次····························································································································2
2、质量控制··································································································································2
三、参考文献··········································································································································2
四、著者····················································································································································2
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中药、天然药物中试研究的技术指导原则
一、概述
中药、天然药物的中试研究是指在实验室完成系列工艺研究后,采用与生产基本相符的条件进行工艺放大研究的过程。
中试研究是对实验室工艺合理性的验证与完善,是保证工艺达到生产稳定性、可操作性的必经环节,是药物研究工作的重要内容之一,直接关系到药品的安全、有效和质量可控。本指导原则为中试研究规模、批次、样品质量、中试场地、设备等相关内容
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