jag009
★★★

NJ,
2025-01-28 21:13
(162 d 17:23 ago)

Posting: # 24352
Views: 1,812
 

 Conducting PK study in Mexico [Regulatives / Guidelines]

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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
 
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