regulatory authorities have a different view [Dissolution / BCS / IVIVC]

posted by Mauricio Sampaio  – Brazil, 2015-09-17 08:44 (3439 d 03:34 ago) – Posting: # 15412
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Well..., According new Draft Guidance published by FDA is very difficult to prove the high solubility of Capecitabine during 24 hours in pH 1. Even though this condition is unreal during administration of this drug (Capecitabine tablets are to be taken orally 30 min after food intake).

Thank you so much for your responses Mr. Dan

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