Bioequivalence and Bioavailability Forum

Intersubject variation in replicated BE study [General Sta­tis­tics]

posted by d_labes  – Berlin, Germany, 2008-03-26 14:34 (6294 d 05:12 ago) – Posting: # 1722
Views: 12,505

Dear Atish,

❝ ... wheather we can calculate intersubject variation in

❝ replicated four period, two sequence, two formulation bioequivalence study

❝ .... SAS software as per the model given in Guidance for

❝ Industry Statistical Approaches to Establishing Bioequivalence ...

The answer lies in your question.
The intersubject variation (separated for Test and Reference) is part of the model of the FDA and therefore part of the output of the SAS code given in Appendix E of the guidance.

Look for G-matrix.

See the threads
forum_entry.php?id=1589
or
forum_entry.php?id=1312
here in the forum and puzzle things together .

Regarding WINNONLIN I am not an initiate.

By the way: Why do you need the intersubject variation?

Complete thread:

• Intersubject variation in replicated BE study atish_azad 2008-03-20 11:33 [General Sta­tis­tics] 
  • Intersubject variation in replicated BE studyd_labes 2008-03-26 13:34
    • Intersubject variation in replicated BE study atish_azad 2008-03-31 15:02
      • Intersubject variation in replicated BE study Jaime_R 2008-03-31 15:09
        • Intersubject variation in replicated BE study atish_azad 2008-04-01 06:15
      • Intersubject variation in replicated BE study d_labes 2008-04-01 10:01
        • Intersubject variation in replicated BE study atish_azad 2008-04-02 15:27