Phase 1 clinical
No requirement for comprehensive and complete validation of analytical methods (specificity, sensitivity, etc. needed)
Degradation pathway and degradation product study of formulation; Refer to ICH Q3B
Potential genotoxic impurity control strategy and analytical information of raw materials; Refer to ICH M7
Phase III clinical
Must have a comprehensive and complete validation of analytical methods focusing on changes in quality standards
Must establish dissolution/release method