Group Effect in Full Replicate Design [RSABE / ABEL]

posted by GM – India, 2018-09-12 17:19 (2076 d 00:22 ago) – Posting: # 19277
Views: 6,816

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:



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:

UA Flag
Activity
 Admin contact
23,029 posts in 4,834 threads, 1,644 registered users;
28 visitors (0 registered, 28 guests [including 7 identified bots]).
Forum time: 17:42 CEST (Europe/Vienna)

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

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