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Development and validation of a sensitive method to quantify a poorly ionized drug, pocapavir, in C57BL/6 mouse
Renmeng Liu1, Ashley Davie1, Elaine To1
1Drug Metabolism, Gilead Sciences Inc., Foster City, CA, USA.
Background:
Pocapavir is an antiviral agent that has shown in vitro potency against poliovirus. It necessitates investigation into its in vivo efficacy and safety profiles. Therefore, the development of a sensitive and reliable bioanalytical method to quantify pocapavir drug levels and characterize its pharmacokinetic (PK) profiles is imperative.
Research Design And Methods:
Given pacapavir's low ionization efficiency, the utilization of atmospheric pressure chemical ionization (APCI) is employed to enhance the assay sensitivity. The developed method is validated and subsequently implemented in a mouse PK study.
Results:
As the first reported bioanalytical method for pocapavir, the method is developed and validated through a full method validation in accordance with the principles of Good Laboratory Practice (GLP), with all evaluated parameters meeting the stipulated acceptance criteria.
Conclusions:
The validated bioanalytical method is suitably equipped to quantify pocapavir while bolstering preclinical and potential applications for first-in-human (FIH) PK characterizations.
