Population Bioequivalence (PBE) analysis for in-vitro studies [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-05-23 08:50  – Posting: # 20296
Views: 1,244

Hello kotu,

» Population Bioequivalence (PBE) analysis is required for in-vitro studies as per FDA guidance for few products like Iron Sucrose Injection, Ciclosporine Ophthalmic Emulsion, Azelastine Nasal spray etc.
»
» For performing PBE analysis there are two statistical methods
» 1. One-sided PBE
» 2. Traditional PBE

I am not sure what is meant here, can you elaborate?
How did you see two options for PBE apart from vague hints that applicants may propose their own methods etc?

PBE is well-defined but largely abandoned for in vivo crossover studies. For in vitro trials, your situation, a variant of PBE was introduced in the Budenoside guidance and it is often your method of choice.

» If the study is meeting criteria as per one-sided PBE analysis & not meeting the criteria as per the traditional PBE analysis, whether that study will be accepted by regulatory?

Rhetorically, you are testing the question using the method you specified in your protocol prior to conducting the experiment.

I could be wrong, but...

Best regards,
ElMaestro

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

Activity
 Admin contact
20,797 posts in 4,354 threads, 1,445 registered users;
online 17 (0 registered, 17 guests [including 9 identified bots]).
Forum time: 06:59 CEST (Europe/Vienna)

The function of genius is not to give new answers, but to pose
new questions which time and mediocrity can resolve.    H.R. Trevor-Roper

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