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RegisterDazed and confused [Design Issues]
posted by Helmut 
– Vienna, Austria, 2020-06-09 18:57 (2210 d 06:00 ago) – Posting: # 21520
Views: 3,413
Hi Libaiyi,
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.
❝ 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.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- How to analyze bioavailable of single arm data comparing a historical control libaiyi 2020-06-09 07:48
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dazed and confusedHelmut 2020-06-09 16:57
- Bridging study? d_labes 2020-06-11 18:27
Ing. Helmut Schütz