Mikalai
★    

Belarus,
2018-10-16 13:42
(1104 d 20:34 ago)

(edited by Mikalai on 2018-10-16 15:35)
Posting: # 19451
Views: 2,419
 

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

Dear friends,
Are there any explicit recommendations or guidelines from EMA about how to establish bio-equivalence for nasal sprays with steroids? 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.
ElMaestro
★★★

Denmark,
2018-10-16 20:35
(1104 d 13:41 ago)

@ Mikalai
Posting: # 19457
Views: 2,007
 

 Product-specific advice (steroid nasal sprays)

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.

Pass or fail!
ElMaestro
Mikalai
★    

Belarus,
2018-10-17 09:40
(1104 d 00:36 ago)

@ ElMaestro
Posting: # 19459
Views: 2,012
 

 Product-specific advice (steroid nasal sprays)

Hello ElMaestro,

» 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.

As I mentioned in my early posts, our NCA needs from time to time to rely on more experienced colleagues. As a result, where can we get quick and not very expensive scientific advice from Europe?
ElMaestro
★★★

Denmark,
2018-10-17 11:56
(1103 d 22:20 ago)

@ Mikalai
Posting: # 19460
Views: 1,989
 

 Product-specific advice (steroid nasal sprays)

Hello Mikalai,

» As I mentioned in my early posts, our NCA needs from time to time to rely on more experienced colleagues. As a result, where can we get quick and not very expensive scientific advice from Europe?

Quick: Sweden
Competent: Sweden, United Kingdom, Germany.
Cheap: Not sure. DK is still at the cheap end, I believe.
Practical (as in, agency acknowledging that perfect dossiers don't exist): Sweden.

All things are relative.:-D

Pass or fail!
ElMaestro
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