Bioequivalence and Bioavailability Forum

Personal experiences… [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2014-04-11 19:58 (4449 d 17:22 ago) – Posting: # 12819
Views: 5,998

Hi Helmut,

❝ I don’t think so – at least I never got a question from a European agency in my studies (passing BE). I simply reported the dissolution at three pHs. I neither calculated ƒ₂ nor did I discuss any­thing.

❝

❝ Other experiences?

Yes but I need to dig it up Will get back to you. Not class 4 though
We did it just to protect our butt.

John

Complete thread:

• Justifications for discrepancy in dissolution vs. BE study gtomer 2014-04-09 14:40 
  • Justifications for discrepancy in dissolution vs. BE study Helmut 2014-04-10 12:31
    • Justifications for discrepancy in dissolution vs. BE study jag009 2014-04-11 15:14
      • Personal experiences… Helmut 2014-04-11 15:22
        • Personal experiences…jag009 2014-04-11 17:58