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

posted by ElMaestro  – Denmark, 2018-10-16 20:35 (1021 d 23:43 ago) – Posting: # 19457
Views: 1,941

Hello Mikalai,

» Are there any explicit recommendations or guidelines from EMA about how to establish bio-equivalence for nasal sprays with steroids?

There is nothing specific yet but they are working on it.

» 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.

You need a scientific advice. There are a ton of companies selling in vitro tests in various flavours and colors and the best I can say of them is that without a scientific advice each and every of those tests may from a regulatory perspective be as good as the south end of a nort-bound horse.

Pass or fail!
ElMaestro

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