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

posted by Mauricio Sampaio  – Brazil, 2015-09-08 22:38 (3442 d 23:39 ago) – Posting: # 15390
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Why FDA indicates a possibility to request a Biowaiver for Capecitabine (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm083276.pdf) and EMA assumes that data on solubility does not allow the BCS classification of capecitabine (http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/07/WC500189272.pdf) ?

If both agencies are based on BCS classification from Amidon, who is correct? :confused:

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