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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.
—
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.
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.
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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