Bioequivalence and Bioavailability Forum

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

posted by Mauricio Sampaio  – Brazil, 2015-09-08 22:38 (3589 d 18:48 ago) – Posting: # 15390
Views: 14,014

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?

Complete thread:

• Biowaiver for Capecitabine - FDA x EMAMauricio Sampaio 2015-09-08 20:38 
  • Biowaiver for Capecitabine - FDA x EMA Dr_Dan 2015-09-09 09:00
    • Biowaiver for Capecitabine - FDA x EMA Mauricio Sampaio 2015-09-09 18:42
  • …as well as the solubility Dr_Dan 2015-09-10 08:52
    • …as well as the solubility Mauricio Sampaio 2015-09-15 06:56
      • regulatory authorities have a different view Dr_Dan 2015-09-15 08:53
        • regulatory authorities have a different view Mauricio Sampaio 2015-09-17 06:44