Group Effect in Full Replicate Design [RSABE / ABEL]
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:
»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?
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:
»
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

—
Best Regards,
GM
Best Regards,
GM
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 DesignGM 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
- Group Effect in Replicate Design zizou 2018-09-12 23:30
- Group Effect in Full Replicate Design Helmut 2018-09-12 15:31
- Group Effect in Full Replicate DesignGM 2018-09-12 15:19
- Group Effect in Full Replicate Design Helmut 2018-09-12 15:09
- Group Effect in Full Replicate Design GM 2018-09-12 13:23
- Group Effect in Full Replicate Design Helmut 2018-09-12 13:08
- Group Effect in Full Replicate Design GM 2018-09-12 12:32
- Group Effect in Full Replicate Design Helmut 2018-09-12 11:20