increased solubility = different PK profile? [Dissolution / BCS / IVIVC]

posted by nobody – 2017-06-08 19:16 (2844 d 02:36 ago) – Posting: # 17462
Views: 14,971

Hi Dr!

To me: That's not how it works with generics. Go for equivalent dissolution and therefore Cmax/AUC. End of story.

Why go for "better" solubility and end up non-BE? ;-) Don't see the point at all.

You could go for some hybrid application in Europe (regulatory is not my piece of cake), but good luck with explaining the "advantage" of your product to the authority(ies) :-D
—
Kindest regards, nobody

Complete thread:

UA Flag
Activity
 Admin contact
23,409 posts in 4,921 threads, 1,669 registered users;
34 visitors (0 registered, 34 guests [including 6 identified bots]).
Forum time: 20:53 CET (Europe/Vienna)

Facts are meaningless. You could use facts to prove
anything that’s even remotely true!    Homer Simpson

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