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

posted by arl_stat – India, 2018-07-13 15:26 (1787 d 23:16 ago) – Posting: # 19046
Views: 4,211

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:

UA Flag
Activity
 Admin contact
22,616 posts in 4,740 threads, 1,614 registered users;
22 visitors (0 registered, 22 guests [including 11 identified bots]).
Forum time: 14:42 CEST (Europe/Vienna)

Mediocrity is a fungus of the mind.    Reif Larsen

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