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Wisdom Talk: Phase-dependent CMC R&D of Innovative New Drugs
创新药研发各阶段的药学考量
简介
创新药的药学研究具有渐进性和不确定性的特点，伴随临床试验的进程，不断获取知识和信息，同时监管的要求也在不断加强。Ⅰ期临床阶段重点关注与安全性有关的药学问题；Ⅱ/Ⅲ期临床阶段持续关注与安全性有关的药学问题、研究期间变更可能带来的安全性风险以及不同研究阶段样品质量的可衔接性；NDA阶段关注质量控制策略的充分性和全面性，核心是保证可持续稳定地生产质量符合要求的产品。
The depth and breadth of CMC research continues to deepen and broaden with the advance of clinical research, which is phase-dependent and accompanying changes. As development proceeds, the data available and regulatory requirements increase until reaching the marketing application. At phase Ⅰ stage, the primary focus is on ensuring the safety of subjects in the proposed study. At phase II/III stage, comparability between different phase samples becomes a concern in addition to safety issues. At NDA stage, the main objective is to assure the continuous high-quality of commercial products.
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