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Mikalai ★ Belarus, 2018-10-16 15:42 (2011 d 11:53 ago) Posting: # 19451 Views: 2,952 |
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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. |
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ElMaestro ★★★ Denmark, 2018-10-16 22:35 (2011 d 05:00 ago) @ Mikalai Posting: # 19457 Views: 2,448 |
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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 |
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Mikalai ★ Belarus, 2018-10-17 11:40 (2010 d 15:55 ago) @ ElMaestro Posting: # 19459 Views: 2,460 |
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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? |
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ElMaestro ★★★ Denmark, 2018-10-17 13:56 (2010 d 13:39 ago) @ Mikalai Posting: # 19460 Views: 2,452 |
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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.  — Pass or fail! ElMaestro |
Ing. Helmut Schütz