Group Effect in Full Replicate Design [RSABE / ABEL]

posted by GM – India, 2018-09-12 15:19 (1235 d 01:02 ago) – Posting: # 19277
Views: 5,575

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 swR <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:ponder:,Which is the correct one?

Best Regards,
GM

Complete thread:

Activity
 Admin contact
21,858 posts in 4,574 threads, 1,554 registered users;
online 17 (0 registered, 17 guests [including 16 identified bots]).
Forum time: Saturday 15:22 CET (Europe/Vienna)

Truth in science can be defined as the working hypothesis best suited
to open the way to the next better one.    Konrad Lorenz

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5