Bioequivalence and Bioavailability Forum

FPP [Dissolution / BCS / IVIVC]

posted by JMCardot  – France, 2018-05-19 12:12 (2527 d 12:56 ago) – Posting: # 18789
Views: 11,548

Dear all

Except if I mistaken I think that the we can simplify it as follow



EMA: Not more than one mean value of > 85% dissolved for any of the formulations.
FDA: Only one measurement should be considered after 85 percent dissolution of both products.

best regards,

Complete thread:

• f2 Calculation For Rapidly Dissolving FPPs Obinoscopy 2018-04-22 15:11 
  • Sample after >85% release Helmut 2018-04-22 16:56
    • Sample after >85% release wienui 2018-04-22 21:39
    • Sample after >85% release Obinoscopy 2018-04-23 00:53
      • Sample after >85% release wienui 2018-04-23 03:32
        • Sample after >85% release Obinoscopy 2018-04-24 13:00
          • Sample after >85% release wienui 2018-04-25 18:46
            • Sample after >85% release Obinoscopy 2018-04-27 02:51
              • Sample after >85% release wienui 2018-04-27 03:23
                • Sample after >85% release Obinoscopy 2018-04-28 20:30
                  • Sample after >85% release Helmut 2018-04-29 13:53
                    • Sample after >85% release Obinoscopy 2018-04-29 22:08
    • FPP Ohlbe 2018-04-23 11:10
      • FPP Helmut 2018-04-24 00:24
        • FPPJMCardot 2018-05-19 10:12