Bioequivalence and Bioavailability Forum • Tweak & Fiddle

Tweak & Fiddle [RSABE / ABEL]

posted by jag009 – NJ, 2013-12-20 18:16 (4570 d 20:05 ago) – Posting: # 12090
Views: 9,858

Hi ElMaestro,

❝ But isn't all this due to SAS trying to create a within-s for A in the covariance matrix, which can't be optimized? It might very well be syntax-dependent, but I am not a SAS user so I do not know which syntax to apply to make SAS understand that only a within-s for B makes sense in V.

So the SAS code is deficient? FDA should point out the need for adjustment I think. Maybe I am too much of a novice in this aspect...

❝ Oh, and on a completely different note: Check AUC-extrapolations of subjs 67, 82.

Yeah I know, the PK data was pulled from the CRO so it was just a snapshot on my behalf for now. They just use WinNonlin to estimate t1/2 and roll out the results.

Oh I encountered another sneaky thing with a CRO, on the bioanalytical side. That's another story, maybe after Xmas I will bring it up...

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 confirmed jag009 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 & Fiddlejag009 2013-12-20 17:16
- Not confirmed - SAS d_labes 2013-12-23 10:14