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

posted by ElMaestro  – Belgium?, 2018-10-16 20:35 (738 d 20:37 ago) – Posting: # 19457
Views: 1,734

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.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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