Bioequivalence and Bioavailability Forum

f2 computation (for pts > 85%) [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2018-09-11 22:00 (771 d 02:22 ago) – Posting: # 19262
Views: 3,118

» » One question related to f2 computation... According to guidance you only include one pt after 85 % release. But for drugs that don't show plateau after 85% (ie; even at one pt after 85%, the curve is still climbing) you have to include addition points right?
»
» Where does that concept come from? And could you put more words to it?
» Also, I am thinking a plateau is something which is hard to debate in a purely measurable way.
»
» Muy confundido

NOT me! My boss said so... I was wondering too.
Does it matter if the drug is an ER or IR?

Thx
John

Complete thread:

• f2 computation (for pts > 85%) jag009 2018-09-10 18:41 [Dissolution / BCS / IVIVC] 
  • f2 computation (for pts > 85%) ElMaestro 2018-09-10 22:52
    • f2 computation (for pts > 85%)jag009 2018-09-12 00:00
  • f2 computation (for pts > 85%) Obinoscopy 2018-09-11 20:21
    • f2 computation (for pts > 85%) jag009 2018-09-12 00:01
      • f2 computation (for pts > 85%) - WHO GL Obinoscopy 2018-09-12 00:38
        • f2 computation (for pts > 85%) - WHO GL Helmut 2018-09-12 01:01
        • f2 computation (for pts > 85%) - WHO GL jag009 2018-09-12 20:35
          • f2 computation (for pts > 85%) - WHO GL ElMaestro 2018-09-12 22:02