Biowaiver for Nasal Sprays [Dissolution / BCS / IVIVC]

posted by ElMaestro  – Denmark, 2014-06-06 02:33 (3971 d 05:46 ago) – Posting: # 13034
Views: 4,125

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

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,686 registered users;
20 visitors (0 registered, 20 guests [including 7 identified bots]).
Forum time: 08:20 CEST (Europe/Vienna)

It is true that many scientists are not philosophically minded
and have hitherto shown much skill and ingenuity
but little wisdom.    Max Born

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5