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

posted by jag009  – NJ, 2018-07-17 08:34 (2551 d 14:53 ago) – Posting: # 19074
Views: 4,856

❝ 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?


Why you are doing multiple dose? FDA does not like multiple dose (unless you are doing b2).

J

Complete thread:

UA Flag
Activity
 Admin contact
23,433 posts in 4,931 threads, 1,674 registered users;
54 visitors (0 registered, 54 guests [including 9 identified bots]).
Forum time: 23:27 CEST (Europe/Vienna)

It has yet to be proven
that intelligence has any survival value.    Arthur C. Clarke

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