Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-07-03 17:02 (1980 d 18:42 ago) – Posting: # 19011
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❝ From a scientific stand point, I think its better both the test and reference product are in the same dosage form before one can waive an invivo BE study and deduce bioequivalence from dissolution studies. This is because excipients play a very important role in BE.

Thanks, Obinoscopy. I agree this is the optimal case, and makes it easier on everyone, but in our case this is not possible. The assumption I posit is that BCS I (and III) drug products are assume to behave like solutions (to a great extent); the high solubility and rapid dissolution producing a solution in the stomach in short notice...practically like it was a solution to begin with. I think this is why there is a requirement for solid dosage forms to undergo dissolution testing and that it be rapid. So, scientifically, I think I make sense, especially when I'm trying to convince myself. :-D

Science and regulations really are strange bedfellows. Maybe Helmet can bring this subject up at the BioBridges conference during the discussion on ICH M9 (hint, hint, nudge, nudge). ;-)

Thanks again for your input.

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