Bridging study? [Design Issues]

posted by d_labes  – Berlin, Germany, 2020-06-11 20:27 (1642 d 17:38 ago) – Posting: # 21528
Views: 2,030

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

Regards,

Detlew

Complete thread:

UA Flag
Activity
 Admin contact
23,336 posts in 4,902 threads, 1,667 registered users;
74 visitors (0 registered, 74 guests [including 13 identified bots]).
Forum time: 13:06 CET (Europe/Vienna)

Every man is fully satisfied that there is such a thing as truth,
or he would not ask any question.    Charles Sanders Peirce

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