Bioequivalence and Bioavailability Forum 16:26 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Ebru Bozkurt
Junior

Turkey,
2017-10-12 14:31

Posting: # 17892
Views: 1,329
 

 How to waive bridging studies by statistical calculations? [Regulatives / Guidelines]

Dear Mr Schütz,

We would like to get information for a deficieny we received from our BA/BE commission regarding a “Bridging study” request.

The case is as follows;
We have a small original oral tablet registered in Japan and under registration in Turkey. During the evaluation of Turkish BA/BE commission, a bridging study is requested. The clinical studies were carried out only on Japanese population but we have four additional PK studies carried out in UK in Caucasians. We provide justifications that our product is ethnically insensitive according to ICH E(5). But the authority is still requesting “Bridging study” with an explanation as given below;

The mentioned ICH E5 guideline may require a “bridging” study even in the presence of an extrapolation area. Besides, comparing the data from the studies on the Caucasian race provided for the said product to the data from studies conducted on a bioequivalent product, inability to perform proper statistical comparisons, fail to meet the criteria for a bridging study.

We would like to clarify whether it is possible to waive the bridging study by carrying out proper statistical comparisons based on PK data already available from caucasian and Japanese.

Regards

Ebru
DavidManteigas
Regular

Portugal,
2017-10-12 19:04

@ Ebru Bozkurt
Posting: # 17893
Views: 1,161
 

 How to waive bridging studies by statistical calculations?

I am not Mr Schütz, but I can't see any statistical calculations that will prevent you from doing a study in Turkey since that seems the opinion of the regulator regardless of any statistics.
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,606 posts in 3,959 threads, 1,208 registered users;
online 21 (2 registered, 19 guests [including 20 identified bots]).

EMEA. The European Medicines Evaluation Agency.
The drug regulatory agency of the European Union.
A statistician-free zone.    Stephen Senn

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