BE and drop out subjects Phoenix [General Sta­tis­tics]

posted by AngusMcLean – USA, 2014-01-24 01:02 (4184 d 10:17 ago) – Posting: # 12252
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We have implemented a 3 way cross-over balanced design (Williams, 6 sequences) for a fed, fasted, sprinkled on food bioequivalence study. It is not a highly variable drug (CV ~15%). The study has gone well and the results are unambiguous. We did lose one subject at PERIOD 3. I am wondering whether I should exclude the other two treatments for this subject prior to BE data analysis in Phoenix. Or should I include all the data I have. Or indeed do the data analysis both ways.

This work is a registration study and will be submitted here to the FDA.

Angus

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