libaiyi
★    

China,
2020-06-09 07:48
(132 d 23:48 ago)

Posting: # 21513
Views: 680
 

 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
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Vienna, Austria,
2020-06-09 16:57
(132 d 14:39 ago)

@ libaiyi
Posting: # 21520
Views: 546
 

 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 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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d_labes
★★★

Berlin, Germany,
2020-06-11 18:27
(130 d 13:09 ago)

@ libaiyi
Posting: # 21528
Views: 493
 

 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
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