Bioequivalence and Bioavailability Forum • Study Design: Two treatment or Four treatment

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

posted by ElMaestro – Denmark, 2023-01-23 16:05 (135 d 17:34 ago) – Posting: # 23434
Views: 926

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."

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Pass or fail!
ElMaestro

Complete thread:

Study Design: Two treatment or Four treatment NK 2023-01-23 09:38 [Design Issues]
- Study Design: Two treatment or Four treatment dshah 2023-01-23 10:43
  - Study Design: Two treatment or Four treatment NK 2023-01-24 03:37
- Study Design: Two treatment or Four treatmentElMaestro 2023-01-23 15:05
  - Study Design: Two treatment or Four treatment Relaxation 2023-01-23 16:10