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Address: 20 Maguire Road, Suite 103, Lexington, MA 02421(America)
Tel: +1(626)986-9880
Address: Allia Future Business Centre Kings Hedges Road Cambridge CB4 2HY, UK
Tel: 0044 7790 816 954
Email: marketing@medicilon.com
Address: No.585 Chuanda Road, Pudong New Area, Shanghai (Headquarters)
Postcode: 201299
Tel: +86 (21) 5859-1500 (main line)
Fax: +86 (21) 5859-6369
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Business Inquiry
Global:
Email:marketing@medicilon.com
+1(626)986-9880(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