Bioequivalence and Bioavailability Forum 11:42 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

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

posted by ElMaestro - Denmark, 2018-07-13 13:42  - Posting: # 19047
Views: 1,119

Hi arl_stat,

» 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?

Yes to everything except (conditionally) the term 'three way' in the context of your post.

if (3) 4

x=c("Foo", "Bar")
b=data.frame(x)
typeof(b[,1]) ##aha, integer?
b[,1]+1 ##then let me add 1



Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,190 posts in 4,085 threads, 1,308 registered users;
online 31 (0 registered, 31 guests [including 13 identified bots]).

The aim of science is not to open the door to infinite wisdom,
but to set a limit to infinite error.    Bertolt Brecht

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