For new drug application for registration, is the pharmacokinetic data required to be accompanied with an analytical method validation report?

刊登日期:2019-11-12  |  點閱次數 : 379 次 

Yes. The correct PK parameters depend on the reliability of the validated analytical method. Therefore, the analytical method should undergo a complete validation to prove the reliability. Please submit the bioanalytical reports of the PK studies and its method validation in your CTD dossier.



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