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RegisterProduct-specific advice (steroid nasal sprays) [Design Issues]
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.
» 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.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Product-specific advice (steroid nasal sprays) Mikalai 2018-10-16 13:42 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Product-specific advice (steroid nasal sprays)ElMaestro 2018-10-16 20:35
- Product-specific advice (steroid nasal sprays) Mikalai 2018-10-17 09:40
- Product-specific advice (steroid nasal sprays) ElMaestro 2018-10-17 11:56
- Product-specific advice (steroid nasal sprays) Mikalai 2018-10-17 09:40
- Product-specific advice (steroid nasal sprays)ElMaestro 2018-10-16 20:35
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