Bioequivalence and Bioavailability Forum

Phoenix/WinNonlin: not confirmed [RSABE / ABEL]

posted by jag009  – NJ, 2013-12-20 18:12 (4570 d 16:32 ago) – Posting: # 12089
Views: 9,881

Hi Helmut,

When I switched to FA0(1) then it worked. using FA0(1):

AUCt: 96.77% 91.88-101.93%
AUCi: 99.71% 95.25-104.38%

So same as yours

FA0(2) works for AUCi but no convergence for AUCt.
For AUCi, results with FA0(2) was the same as FA0(1).

Question is why FA0(2) didn't work? I am not a saint in statistics yet so I don't know

❝ seems to be a pivotal study this time?

Yes, they didn't listen and went with 3/4 of the subjects (of this current panel) last time, guess what happened...

Thanks
John

Complete thread:

• tada: Another issue with FDA's RSABE (please confirm?) jag009 2013-12-19 17:41 
  • Phoenix/WinNonlin: not confirmed Helmut 2013-12-20 04:13
    • Phoenix/WinNonlin: not confirmedjag009 2013-12-20 17:12
      • TRT|RTR or FA0(1) Helmut 2013-12-20 17:37
        • TRT|RTR or FA0(1) jag009 2013-12-20 21:24
        • Partial replicate crap? Really? d_labes 2013-12-23 09:18
          • Partial replicate crap? Really? Helmut 2013-12-23 14:06
  • Tweak & Fiddle ElMaestro 2013-12-20 14:32
    • Tweak & Fiddle jag009 2013-12-20 17:16
  • Not confirmed - SAS d_labes 2013-12-23 10:14