| 简介/内容概述： | This guideline applies to analytical procedures used for release and stability testing of commercial drug substances and products, hereafter referred to as ‘products’. The guideline can also be applied to other analytical procedures used as part of the control strategy (ICH Q10 Pharmaceutical Quality System) following a risk-based approach. The scientific principles described in this guideline can be applied in a phase-appropriate manner to analytical procedures used during clinical development. |
