Bioequivalence and Bioavailability Forum • Fully Replicated design

Fully Replicated design [RSABE / ABEL]

posted by Dr_Dan – Germany, 2013-09-24 13:17 (4250 d 06:04 ago) – Posting: # 11546
Views: 7,758

Dear sirajudeen

subjects who completed at least one period with Test and at least one other period with reference can be considered for PK and stat evaluation.
subjects who completed two periods of Test products can be considered for within-subject variability of the test product (this is the idea of the full replicate to evaluate the within-subject variability of the reference as well as of the test product).
all subjects which allow a comparison of test and reference should be included in the statistical evaluation (as mentioned above: at least one period with Test and at least one other period with reference). So the subjects could complete 2, 3 or 4 periods.

I hope this helps.
Kind regards
Dan

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Kind regards and have a nice day
Dr_Dan