Biowaiver for Capecitabine - FDA x EMA [Dissolution / BCS / IVIVC]

posted by Dr_Dan  – Germany, 2015-09-09 11:00 (3441 d 14:40 ago) – Posting: # 15391
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Dear Mauricio
capecitabine is unstable in acidic medium and in the opinion of EMA this does not allow the BCS classification of capecitabine. IMHO this is nonsense or at least no argument against a biowaiver. Stability in acidic media is a substance specific property. The aim of a BE study is to show possible differences in formulation. If both formulation rapidly disintegrate and the API is dissolved within 15 min. what would be the advantage of a BE study? Once dissolved capecitabine from the test formulation would be affected with regard to stability in the same way as capecitabine from the reference formulation, right?
I had the same discussion with a different drug and finally the biowaiver was accepted, but it is a case by case decision. BTW I do not like the EMA product specific bioequivalence recommendations. I think These are not well elaborated.
I hope this helps.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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