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

posted by arl_stat – India, 2018-07-13 13:26 (802 d 01:58 ago) – Posting: # 19046
Views: 3,044

Greetings to all.

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?

Kindly share any reference article if any.

Thank you !!!


Edit: Category changed; see also this post #1[Helmut]

Complete thread:

Activity
 Admin contact
21,071 posts in 4,393 threads, 1,466 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Tuesday 15:24 CEST (Europe/Vienna)

Everybody is a Bayesian.
It’s just that some know it, and some don’t.    Trivellore Raghunathan

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