Group Effect in Full Replicate Design [RSABE / ABEL]

posted by GM – India, 2018-09-12 15:19 (974 d 22:05 ago) – Posting: # 19277
Views: 4,898

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
21,460 posts in 4,486 threads, 1,513 registered users;
online 15 (1 registered, 14 guests [including 3 identified bots]).
Forum time: Friday 13:25 CEST (Europe/Vienna)

Art is “I”; science is “we”.    Claude Bernard

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