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

posted by NK – India, 2023-01-23 10:38 (843 d 22:54 ago) – Posting: # 23431
Views: 4,009

Hello Everyone,

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?
Kindly suggest any reference.

Regards
NK

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,672 registered users;
165 visitors (0 registered, 165 guests [including 9 identified bots]).
Forum time: 10:32 CEST (Europe/Vienna)

A statistical analysis, properly conducted, is a delicate dissection of
uncertainties, a surgery of suppositions.    Micheal J. Moroney

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