Challenges and Opportunities for In Vitro–In Vivo Extrapolation of Aldehyde Oxidase-Mediated Clearance: Toward a Roadmap for Quantitative Translation
Nihan Izat,
Jayaprakasam Bolleddula,
Armina Abbasi
et al.
Abstract:Underestimation of AO-mediated clearance by current in vitro assays leads to uncertainty in human dose projections, thereby reducing the likelihood of success in drug development. In the present study we first evaluated the current drug development practices for AO substrates. Next, the overall predictive performance of in vitro-in vivo extrapolation (IVIVE) of unbound hepatic intrinsic clearance (CL int,u ) and unbound hepatic intrinsic clearance by AO (CL int,u,AO ) was assessed using a comprehensive literat… Show more
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