Bioequivalence and Bioavailability Forum

Hi,

Has anyone conducted PK study in Mexico with a local CRO? I am planning to run a BE study in Mexico (for Mexico submission). The local CRO said as per COFERPRIS regulation, the CRO must carry out bioanalysis, PK and statistical analyses. Is that true? I understand the req't for bioanalysis but the data analysis needs to be done by the CRO as well? Can't the client carry out his/her own PK & stat & safety analyses and insert into the PK report? Isn't this strange?

Thx
J