Full-replicate design in two groups [General Sta­tis­tics]

posted by Mikalai  – Belarus, 2018-10-31 14:04 (1089 d 18:20 ago) – Posting: # 19510
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Dear all,
We are conducting a full replicate design study. Due to recruiting difficulties we had to split the study in two groups. It has been suggested that we should change our statistical model to model II of FDA. What risks, if any, carry on this model to our bioequivalence? Can additional factors in model artificially reduce our CV and push us out of the scaled approach to usual 125%-80% one (I am not a statistician, so my question may be statistically correct)? Should we change our usual 4-factor model?

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