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RegisterHow 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
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
Complete thread:
- How to analyze bioavailable of single arm data comparing a historical controllibaiyi 2020-06-09 07:48 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dazed and confused Helmut 2020-06-09 16:57
- Bridging study? d_labes 2020-06-11 18:27
Ing. Helmut Schütz