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

posted by ElMaestro  – Denmark, 2023-01-23 16:05 (400 d 17:57 ago) – Posting: # 23434
Views: 1,641

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

Complete thread:

UA Flag
Activity
 Admin contact
22,912 posts in 4,806 threads, 1,636 registered users;
38 visitors (0 registered, 38 guests [including 7 identified bots]).
Forum time: 10:03 CET (Europe/Vienna)

Exploratory analysis: The art of finding a Rembrandt
in a Jackson Pollock.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5