Bioequivalence and Bioavailability Forum

‘dlat’ for 3-period full replicate? [RSABE / ABEL]

posted by mittyri – Russia, 2023-07-07 18:04 (556 d 07:05 ago) – Posting: # 23661
Views: 3,471

Hi Helmut!

❝ I have a problem (both in Phoenix/WinNonlin, R, and – likely – in SAS as well). To calculate s_wR the FDA wants a linear model (in SAS-lingo proc glm) of repeated reference data with subject as a factor. However, in a 3-period full replicate they are all in one sequence and the model collapses. Now what?

you discovered another point for a lecture
So the problem is here
proc glm data=scavbe;
  class seq;
  model dlat=seq;
  ods output overallanova=dglm1;
  ods output NObs=dglm3;
  title1 'scaled average BE';
run;

I would look at the original formula

\(s_\text{wR}^2=\Large\frac{\sum\limits_{i=1}^{m}\sum_\limits{j=1}^{n_i}\left(D_{ij}-\overline{D}_{i\,\cdot}\right)^2}{2\left(n-m\right)}\)

So it is impossible to get D for `TRT` sequence. Could we just omit one sequence here?

Complete thread:

• any SAS or R-macro for 3 period two sequence RSABEIs Achievwin 2023-07-05 18:38 [RSABE / ABEL] 
  • Use the one for TRTR | RTRT Helmut 2023-07-06 08:46
    • RSABE R coded by Detlew mittyri 2023-07-06 14:07
      • ‘dlat’ for 3-period full replicate? Helmut 2023-07-07 14:41
        • ‘dlat’ for 3-period full replicate?mittyri 2023-07-07 16:04
          • Likely wrong workaround? Helmut 2023-07-07 20:06
            • a bit corrected workaround mittyri 2023-07-07 22:52
              • THX! Another attempt… Helmut 2023-07-08 12:15
                • complete.cases for dlat and ilat? mittyri 2023-07-09 21:45
              • a bit corrected workaround Achievwin 2023-07-10 20:43