Bioequivalence and Bioavailability Forum 14:17 CEST

Group Effect in Full Replicate Design [RSABE / ABEL]

posted by GM - India, 2018-09-12 15:19  - Posting: # 19277
Views: 278

Dear Helmut,

Thank you very much for the clarification. One more last question...

» » » Honestly, I have no clue how to modify the models given in the progesterone-guidance.
»
» Specifically the scaling-part…
» For the ABE part (if s_wR <0.294) like the FDA’s Model II:

• fixed:
  » Group, Sequence, Treatment, Period (nested within Group), Group-by-Sequence Interaction
  »
• random:
  » Subject (nested within Group × Sequence)

But as per Progesterone Guidance, Treatment as random term in Average BE.

Please see model SAS code from guidance.

MODEL LAUCT = SEQ PER TRT/ DDFM=SATTERTH;
RANDOM TRT/TYPE=FA0(2) SUB=SUBJ G;

As per your version, Subject (nested within Group × Sequence) is the random term.

Now am Confused,Which is the correct one?

Complete thread:

• Group Effect in Full Replicate Design - GM, 2018-09-12 07:17 [RSABE / ABEL] 
  • Group Effect in Full Replicate Design - Helmut, 2018-09-12 11:20
    • Group Effect in Full Replicate Design - GM, 2018-09-12 12:32
      • Group Effect in Full Replicate Design - Helmut, 2018-09-12 13:08
        • Group Effect in Full Replicate Design - GM, 2018-09-12 13:23
          • Group Effect in Full Replicate Design - Helmut, 2018-09-12 15:09
            • Group Effect in Full Replicate Design - GM, 2018-09-12 15:19
              • Group Effect in Full Replicate Design - Helmut, 2018-09-12 15:31
                • Group Effect in Replicate Design - zizou, 2018-09-12 23:30
                  • Group Effect in Replicate Design - Helmut, 2018-09-13 11:34