浅谈口服固体仿制药制剂研发风险管理

Talking of the Risk Management of Oral Solid Generic Drug Preparation R&D

根据风险管理理论,结合实际项目经验,依次进行了项目的风险识别、风险分析、风险评估、风险控制,强调研发全周期持续的风险评价和监控,以确保项目顺利进行,对口服固体仿制药制剂研发有一定借鉴意义。

According to the theory of risk management and the practical experience of the project,the risk identification,risk analysis,risk assessment and risk control of the project are carried out in turn.The continuous risk assessment and monitoring in the whole R&D cycle is emphasized to ensure the smooth progress of the project,which has certain reference significance for the research and development of oral solid generic drugs.