Bioequivalence and Bioavailability Forum • Second opinion (PHX 6.3)

Second opinion (PHX 6.3) [RSABE / ABEL]

posted by jag009 – NJ, 2013-05-01 19:16 (4433 d 16:24 ago) – Posting: # 10518
Views: 25,233

Thank you Helmut!

Detlew, need help! :-)

Here is the covariance output from SAS on ln AUCt

Covariance Parameter Estimates

Cov Parm  Subject       Group         Estimate

FA(1,1)   subject                     0.4427

FA(2,1)   subject                     0.4236

FA(2,2)   subject                     0.2481

Residual  subject   formulation Ref   0.05301

Residual  subject   formulation Test  0.02648

Question, what does the residual "formulation Test" represent? Is it the residual attributed to both test and ref, while residual "formulation ref" is attributed to the ref (since it was given 2x)? which one would one use to compute the 90% geometric CI then?

❝ IMHO, since a partial replicate according to FDA’s model is always (!) overspecified there is no guarantee that the LME-engines will converge. Don’t blame SAS and PHX; they warn us… Stupid design. If you want to have only three periods maybe it is better to run a fully replicated design (TRT|RTR) in the future.

Any hint on the stat approach?

Thanks
John

Complete thread:

FDA's HVD SAS Code from Progesterone Guidance jag009 2013-04-22 16:39 [RSABE / ABEL]
- Proc MIXED vs. Proc GLM Helmut 2013-04-22 17:47
  - Proc MIXED vs. Proc GLM jag009 2013-04-22 20:33
    - SAS vs. PHX Helmut 2013-04-22 22:10
      - SAS vs. PHX Shuanghe 2013-04-23 11:45
        
        SAS vs. SAS d_labes 2013-04-23 16:50
        
        SAS vs. SAS vs. Phoenix Helmut 2019-11-12 13:01
      - SAS vs. PHX jag009 2013-04-23 15:56
        
        SAS Warning (Note) on Proc Mixed jag009 2013-04-23 17:07
        
        Nut Job.. jag009 2013-04-30 21:09
        
        Second opinion (PHX 6.3) Helmut 2013-05-01 16:21
        
        Second opinion (PHX 6.3)jag009 2013-05-01 17:16
        
        Second opinion (PHX 6.3) ElMaestro 2013-05-01 18:48
        In praise of a full replicate Helmut 2013-05-01 19:16
        Third opinion d_labes 2013-05-02 12:00
        
        Compound Symmetry Helmut 2013-05-02 14:41
        
        Compound Symmetry - SASian (1) d_labes 2013-05-02 16:26
        
        Variance=0 Helmut 2013-05-03 16:07