Bioequivalence and Bioavailability Forum

Additional excipient justification [Dissolution / BCS / IVIVC]

posted by nobody – 2014-12-02 11:38 (3793 d 03:30 ago) – Posting: # 13966
Views: 6,429

I don't think there is kind of "generic" justification, I would go for a specific API, specific excipient and regulator... In depth analysis from known and unknown unknows from the literature. Piece of work but cheaper and faster than biostudy. In case of no success (during Sci Adv) go ahead with BE studie, or?

Complete thread:

• Additional excipient justification srinivasuk 2014-11-30 08:53 [Dissolution / BCS / IVIVC] 
  • Biowaiver for BCS Class II? Helmut 2014-11-30 14:24
  • Additional excipient justification nobody 2014-11-30 20:44
    • Additional excipient justification Dr_Dan 2014-12-02 09:34
      • Additional excipient justificationnobody 2014-12-02 10:38