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

posted by Ebru Bozkurt - Turkey, 2017-10-12 14:31  - Posting: # 17892
Views: 1,448

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.



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I have had my results for a long time:
but I do not yet know how I am to arrive
at them.    Carl Friedrich Gauß

BEBAC Ing. Helmut Schütz