Subjects in replicate BE study EU [RSABE / ABEL]

posted by mittyri – Russia, 2015-03-19 20:12 (2497 d 04:52 ago) – Posting: # 14581
Views: 25,165

Dear Relaxation and all,

Your suggestions seems very interesting!

» even subjects without data for a T vs R comparison have an impact

I'm not sure that the subjects without T vs R comparison should be included in the analysis according to the EMA GL:
[…] subjects in a crossover trial who do not provide evaluable data for both of the test and reference products […] should not be included.

Also see this post

Kind regards,

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