Business Inquiry
Global:
Email:marketing@medicilon.com
+1 (617) 888-9294(U.S.)
0044 7790 816 954 (Europe)
China:
Email: marketing@medicilon.com.cn
Tel: +86 (21) 5859-1500
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