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• W2918085087 abstract "Accurately predicting the hepatic clearance of compounds using in vitro to in vivo extrapolation (IVIVE) is crucial within the pharmaceutical industry. However, several groups have recently highlighted the serious error in the process. Although empirical or regression-based scaling factors may be used to mitigate the common underprediction, they provide unsatisfying solutions because the reasoning behind the underlying error has yet to be determined. One previously noted trend was intrinsic clearance-dependent underprediction, highlighting the limitations of current in vitro systems. When applying these generated in vitro intrinsic clearance values during drug development and making first-in-human dose predictions for new chemical entities though, hepatic clearance is the parameter that must be estimated using a model of hepatic disposition, such as the well-stirred model. Here, we examine error across hepatic clearance ranges and find a similar hepatic clearance-dependent trend, with high clearance compounds not predicted to be so, demonstrating another gap in the field." @default.
• W2918085087 created "2019-03-02" @default.
• W2918085087 creator A5026814664 @default.
• W2918085087 creator A5075960682 @default.
• W2918085087 date "2019-07-01" @default.
• W2918085087 modified "2023-10-12" @default.
• W2918085087 title "In Vitro-In Vivo Extrapolation and Hepatic Clearance-Dependent Underprediction" @default.
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• W2918085087 doi "https://doi.org/10.1016/j.xphs.2019.02.009" @default.
• W2918085087 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/7325626" @default.
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