Business Inquiry
Global:
Email:marketing@medicilon.com
+1(781)535-1428(U.S.)
0044 7790 816 954 (Europe)
China:
Email: marketing@medicilon.com.cn
Tel: +86 (21) 5859-1500
Phase I clinical
◆ Stability data should support the formulation to meet the requirements during the clinical study
Phase III clinical trials
◆ Use currently prepared products for compatibility stability studies
◆ Use Multi-dose packaging (except solid oral formulations) to provide the necessary stability after package opening
◆ To ensure sufficient stability data in NDA, it is recommended to provide a formal stability study program