Introduction: 725 Discussion: 1251 Abbreviations: AAFE, absolute average fold error; AUC, area under the plasma concentrationtime curve; B/P ratio, blood-to-plasma ratio; C max , peak plasma concentration; CL int,u , unbound hepatic intrinsic clearance; CL r , renal clearance; C ss , steady-state concentration; CYP3A7, cytochrome P450 3A7; ER, hepatic extraction ratio; FLM, fetal liver microsomes; f u , fraction unbound in plasma; GFR, glomerular filtration rate; HPLC-MS/MS, high performance liquid chromatography with tandem mass spectrometry; IV, intravenous; K p , tissue partitioning coefficients; MA, maternal artery; mf-PBPK model, maternal-fetal physiologically-based pharmacokinetic model; MV, maternal vein; t max , time to reach C max ; UV, umbilical vein; UA, umbilical artery; V ss , steady-state volume of distribution;