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

posted by ElMaestro - Denmark, 2018-10-16 20:35  - Posting: # 19457
Views: 280

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.

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

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