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FAQs

The Key of Stability Studies in Phase I and Phase III Clinical Trials

Phase I clinical 

 ◆ Stability data should support be able to support the formulation to meet the requirements during the clinical study 

Phase III clinical trials 

 ◆ Use of currently prepared products for compatibility stability studies 

 ◆ 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