Study Design- Two treatment or Four treatment [Design Issues]

posted by ElMaestro  – Denmark, 2023-01-23 16:05 (15 d 09:08 ago) – Posting: # 23434
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Hi NK

❝ We are planning a BE study with four arms (Test product under fasting, Test product under fed, Reference under fasting & Reference under fed) with two treatments (test and Reference). In this case, please clarify the study title to be mentioned as "Two treatment, Two sequence" or "Four treatment, two sequence" Bioequivalence study?


You can call it something like "a two-treatment, two-period, two-sequence randomised BE study in two cohorts (fed and fasted) to investigate similarity in rate and extent of absorption of Blahblah vs Blahblahblah in healthy adult volunteers."

Pass or fail!
ElMaestro

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