Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-09-12 17:09 (2469 d 17:12 ago) – Posting: # 19276
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Hi Gm,

❝ We don't want to take any decisions on the basis of model terms.


Very good.

❝ Our thought is, we need to check group effect for both ABE and RSABE also.


Again: you have to include “group” as a factor in various ways (see below).

❝ If this correct, how the model is to be designed for RSABE?


As I wrote above

❝ ❝ 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:

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