Bioequivalence and Bioavailability Forum

SAS error in 3 way ref replicate study [RSABE / ABEL]

posted by AB – India, 2012-05-04 17:13 (4717 d 08:50 ago) – Posting: # 8514
Views: 16,659

Dear all,

we have done a BE study in 3 way ref replicate design for FDA and ended up with the following error while running SAS code for unscaled 90% bioequivalence confidence intervals as given in "Draft Guidance on Progesterone" for parameter AUCI.

"NOTE: 20 observations are not included because of missing values.
WARNING: Did not converge."

These missing 20 observations are the ones (AUCI) which were not caculated in the respective treatment groups as the r² values are less than 80%.

However, when we re run the data including these 20 missing AUCI (recalculated without considering the r² criteria), there was no error.

plz suggest what is the correct way to deal with this?

Thanks in advance

Complete thread:

• SAS error in 3 way ref replicate studyAB 2012-05-04 15:13 [RSABE / ABEL] 
  • SAS error in 3 way ref replicate study jag009 2012-05-04 15:36
    • SAS error in 3 way ref replicate study AB 2012-05-05 06:45
  • FDA's ABE code and partial replicate design d_labes 2012-05-06 10:10
    • Arbitrary (and unjustified) cut-off of r² Helmut 2012-05-06 13:29
      • Anscombe quartet d_labes 2012-05-07 08:48
        • Anscombe quartet in R Helmut 2012-05-07 11:15
          • Anscombe quartet in R AB 2012-05-07 12:07
      • Arbitrary (and unjustified) cut-off of r² FI 2012-10-08 10:39
        • Predominant half life; exclusions Helmut 2012-10-08 13:45
          • Excluding time points for lambdaZ d_labes 2012-10-09 09:33
            • Analytical variability Helmut 2012-10-09 14:09
              • Answer machine d_labes 2012-10-09 15:15
                • Well done! Helmut 2012-10-09 19:43