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

posted by libaiyi – China, 2020-06-09 07:48 (340 d 08:35 ago) – Posting: # 21513
Views: 935

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,

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