Mauricio Sampaio
★    

Brazil,
2014-06-05 23:39
(4050 d 11:09 ago)

Posting: # 13033
Views: 5,303
 

 Biowaiver for Nasal Sprays [Dissolution / BCS / IVIVC]

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Which in vitro tests are needed to biowaiver for Nasal Sprays of other strenghts when bioequivalence is accepted to one strenght? I am considering a PK study.
 
ElMaestro
★★★

Denmark,
2014-06-06 02:33
(4050 d 08:15 ago)

@ Mauricio Sampaio
Posting: # 13034
Views: 4,264
 

 Biowaiver for Nasal Sprays

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Hi Mauricio,

❝ Which in vitro tests are needed to biowaiver for Nasal Sprays of other strenghts when bioequivalence is accepted to one strenght? I am considering a PK study.


Where do you intend to submit? Did you enter a dialogue with regulators? Are we talking mometasone? Did you compare particle size distribution profiles?
—
Pass or fail!
ElMaestro
 
Mauricio Sampaio
★    

Brazil,
2014-06-10 23:58
(4045 d 10:50 ago)

@ ElMaestro
Posting: # 13055
Views: 4,307
 

 Biowaiver for Nasal Sprays

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I am talking about budesonide nasal spray. Is there any method proposed?
 
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