BE and drop out subjects Phoenix [General Sta­tis­tics]

posted by AngusMcLean – USA, 2014-01-24 01:02 (3717 d 06:08 ago) – Posting: # 12252
Views: 7,507

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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
95 visitors (1 registered, 94 guests [including 9 identified bots]).
Forum time: 07:10 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5