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FAQs

Differencese of Quality Research Between Phase Ⅰ and Ⅲ?

Phase 1 clinical 

No need for comprehensive and complete validation of analytical methods (need for specificity, sensitivity, etc.) 

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 

The need for a comprehensive and complete validation of analytical methods which focus on changes in quality standards Need to establish dissolution/release method