libaiyi
★    

China,
2020-06-09 09:48
(1645 d 03:27 ago)

Posting: # 21513
Views: 2,611
 

 How to analyze bioavailable of single arm data comparing a historical control [Design Issues]

Dear all,

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?


Best regareds,
Libaiyi
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2020-06-09 18:57
(1644 d 18:18 ago)

@ libaiyi
Posting: # 21520
Views: 2,039
 

 Dazed and confused

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
d_labes
★★★

Berlin, Germany,
2020-06-11 20:27
(1642 d 16:47 ago)

@ libaiyi
Posting: # 21528
Views: 2,030
 

 Bridging 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

Regards,

Detlew
UA Flag
Activity
 Admin contact
23,336 posts in 4,902 threads, 1,668 registered users;
44 visitors (1 registered, 43 guests [including 9 identified bots]).
Forum time: 12:15 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