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

posted by ElMaestro  – Denmark, 2017-06-08 20:45 (2512 d 19:02 ago) – Posting: # 17470
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Hi Dr_Dan,


❝ O.k., I see I need to add some more information. The idea behind this question is to develop an oral formulation with a less drug load than the reference product but with the same bioavailability in order to decrease non-systemic adverse events.


"To support safety, it should be demonstrated that the systemic exposure is not higher for the test product than for the reference product, i.e. the upper limit of the 90% confidence interval should not exceed the upper bioequivalence acceptance limit 125.00."

Taken from section 3.4 here.

In my experience it is enforced the way it is written and even though 3.4 deals with OIP&scaling the sentence is enforced verbatim even in situations where scaling is not a topic when a 10.3 submission is foreseen even if it isn't an OIP.
Pick the right agency. I can't emphasize it enough. :ok::pirate:
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Pass or fail!
ElMaestro

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