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

posted by nobody – 2017-06-08 19:16 (3293 d 12:35 ago) – Posting: # 17462
Views: 17,441

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

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