Bioequivalence and Bioavailability Forum

Hi Libaiyi,

❝ I had PK data from US. And now this drug needs to be put into other regions such as Asia. So we setup a new study, it is a single arm trial. How can I compare the PK data from the new trial to historical US PK data?

Never came across such a design.
Most agencies require a local reference product. Then you end up with a new comparative study. The US study is not relevant.
In the rare case where an agency accepts a foreign reference product (in your case the RLD), you could submit the US study.

Dear Libaiyi,

❝ Now I met a study design and analysis method problem. I had PK data from US. And now this drug needs to be put into other regions such as Asia. So we setup a new study, it is a single arm trial. How can I compare the PK data from the new trial to historical US PK data?

Like Helmut I also never came across such a design during my active working period.

But eventually your problem is something like "Bridging study".
Have a look into the paper
Jen-pei Liu
'Bridging Bioequivalence Studies'
J Biopharm Stat. 2004 Nov;14(4):857-67.
doi: 10.1081/BIP-200035418

This paper is also handled in
Shein-Chung Chow, Jen-pei Liu
Design and Analysis of Bioavailability and Bioequivalence Studies
Third Edition, Chapter 20.3
Chapman & Hall/CRC
Boca Raton 2009