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

posted by jag009  – NJ, 2018-07-17 04:34 (919 d 00:12 ago) – Posting: # 19074
Views: 2,733

» 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:

Activity
 Admin contact
21,308 posts in 4,444 threads, 1,489 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Thursday 04:46 UTC (Europe/Vienna)

Politicians use statistics like drunkards use lampposts:
not for illumination, but for support.    attributed to Hans Kuhn

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