Bioequivalence and Bioavailability Forum 04:31 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Group Effect in Full Replicate Design [RSABE / ABEL]

posted by GM - India, 2018-09-12 15:19  - Posting: # 19277
Views: 1,015

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,037 posts in 4,061 threads, 1,301 registered users;
online 8 (0 registered, 8 guests [including 8 identified bots]).

An expert is a man who has made all the mistakes,
which can be made, in a very narrow field.    Niels Bohr

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed