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FAQs

Differencese of Quality Research Between Phase Ⅰ and Ⅲ?

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