Subjects to be considered in partial replicate BE study [RSABE / ABEL]

posted by Dr_Dan  – 2015-01-08 08:59 (2567 d 16:23 ago) – Posting: # 14245
Views: 27,187

Dear Detlew
I agree that the study protocol text is insufficiently verbalized. However, if a subject completes two periods, he/she can be included either in the assessment of bioequivalence (in case of one period with test and the other with reference) or in the assessment of within-subject variability of the reference product (in case both periods with reference), right?
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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