Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-04-29 01:43 CEST (UTC+2h)
 

Replicate or not? [Design Issues]

posted by Mikkabel - Belgium, 2017-02-16 12:18  - Posting: # 17068
Views: 1,056

Hello,

I am new as user of the forum (but not as a viewer) and it is my first question, so please be undestanding with me.....;-)

My company plan to perform a 4-arm PK study with two arms for two different doses of the test formulations and two arms for two different batches of the reference treatment.

Even if two different batches of the reference treatment will be used, could you please advice me if I can considered this design as a replicate design?
Furthermore, on a statistical point of view, is it correct to use the within-subject variability of the reference obtained with this design to widen the acceptance criteria for Cmax?

thank you in advance for your response,
have a nice day!

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
16,784 Posts in 3,605 Threads, 1,033 registered users;
16 users online (0 registered, 16 guests).

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

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