Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-21 02:01 CEST (UTC+2h)

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

posted by arl_stat - India, 2018-07-13 13:26  - Posting: # 19046
Views: 275

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,547 posts in 3,941 threads, 1,190 registered users;
online 12 (0 registered, 12 guests [including 12 identified bots]).

In the field of observation,
chance favors only the mind that is prepared.    Louis Pasteur

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed