Comparing two plasma concentration profiles [Study As­sess­ment]

posted by Darborn – Taiwan, 2025-10-21 03:02 (244 d 07:09 ago) – Posting: # 24468
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Hi Helmut,

I may add some background information.
China's regulatory agency (NMPA/CDE) refused to approve multiple highly-variable products which conducted their bioequivalence study in a four-period crossover design. The reason for this acion was based on "The similarity of plasma-concentration curves of the same subject between TEST and REFERENCE is larger than the similarity between two repeated REFERENCE".
I tried to calculate the f2 factor using the Cmax value of the reference product as a correction factor, and I found many different products had a similar pattern that "The similarity of plasma-concentration curves of the same subject between TEST and REFERENCE is larger than the similarity between two repeated REFERENCE".
I believe this is due to the nature of highly-variable products and randomness, but I am not sure if this is correct. Does FDA or EMA have similar statments?

Thanks

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