Biowaiver only for BCS I and – under certain conditions – BCS III drugs [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 11:27 (235 d 06:10 ago) – Posting: # 21710
Views: 1,001

Hi Steven,

THX! I was not aware of this one (should have searched my own guideline collection).

» https://www.ema.europa.eu/en/rivaroxaban-product-specific-bioequivalence-guidance

@dshah

BCS Classification  BCS Class: ☐ I  ☐ III   Neither of the two
                    Background: rivaroxaban may be considered a low solubility compound.

… is the end of the story.

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