Multiple Dose, Steady State-Partial reference replicate [Design Issues]

posted by ElMaestro  – Denmark, 2018-07-13 15:42 (2498 d 15:29 ago) – Posting: # 19047
Views: 4,801

Hi arl_stat,

❝ Please help in understanding whether it is possible to conduct “An open-label, randomized, Multiple Dose, Steady State, two treatments, three periods, three sequence, three way, Reference Replicated crossover bioequivalence study” for USFDA Submission?


Yes to everything except (conditionally) the term 'three way' in the context of your post.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,672 registered users;
135 visitors (0 registered, 135 guests [including 8 identified bots]).
Forum time: 07:11 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