Model qualification of the PK-Sim® pediatric module for pediatric exposure assessment of CYP450 metabolized compounds - Yun, Yejin Esther; Edginton, Andrea N. (Journal of Toxicology and Environmental Health, Part A, 2019)
Keywords: Adolescent; Adolescents; Adult; adult-to-children PK extrapolation; Algorithms; Body height; Child; Child, Preschool; Children; Coefficient of variation; Computer Simulation; Confidence; Cytochrome; Cytochrome P-450 Enzyme System - metabolism; Cytochrome P450; Cytochromes P450; Exposure; Health risks; Humans; Infant; Infant, Newborn; Infants; Liver; Mathematical models; Metabolism; model qualification; Modelling; Models, Biological; Neonates; Organic chemistry; Parameter estimation; Parameter identification; Parameter sensitivity; PBPK; Pediatric physiologically based pharmacokinetic modeling; Pediatrics; Performance prediction; Pharmaceutical Preparations - metabolism; Pharmacokinetics; Pharmacology; Populations; Risk assessment; Sensitivity analysis; Variability; PBPK; Pediatric physiologically based pharmacokinetic modeling; model qualification; adult-to-children PK extrapolation