Product-specific advice (steroid nasal sprays) [Design Issues]

posted by Mikalai  – Belarus, 2018-10-16 11:42 (774 d 15:58 ago) – Posting: # 19451
Views: 2,133

(edited by Mikalai on 2018-10-16 13:35)

Dear friends,
Are there any explicit recommendations or guidelines from EMA about how to establish bio-equivalence for nasal sprays with steroids? More specifically, how can we avoid a therapeutic equivalence study, European approach? Are there any recommendations on Morphologically-Directed Raman Spectroscopy (MDRS) as a substitute for a therapeutic equivalence study? Any references will be appreciated.

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