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RegisterConducting PK study in Mexico [Regulatives / Guidelines]
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
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
Complete thread:
- Conducting PK study in Mexicojag009 2025-01-28 20:13
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Ing. Helmut Schütz