Bioequivalence and Bioavailability Forum

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.