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JAMA 2022, 328 (8), 754–771

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Explanations of lack of IVIVE have most commonly been attributed to (1) extrinsic factors such as the loss of enzymatic activity due to suboptimal storage or preparation of human liver tissues or due to the presence of metabolic inhibitors present during the isolation process, (2) the inability of in vitro incubations to recapitulate hepatic architecture, (3) nonspecific or protein binding that is not fully accounted for in clearance prediction calculations, (4) a neglected contribution of extrahepatic clearance or other clearance mechanisms, or (5) the potential differences between the donors of liver tissue and the young healthy volunteers in which clinical clearance determinations are conducted