Prediction of Drug Clearance in Preterm and Term Neonates by Minimal Physiologically Based Pharmacokinetic Model and Allometry: A Comparison with Whole BODY Physiologically Based Pharmacokinetic Model

Objectives: The objective of this study is to compare the predictive performance a minimal physiologically based Pharmacokinetic model (mPBPK) and an allometric with whole body pharmacokinetic Model (PBPK) predict clearance drugs in preterm term neonates. Methods: From literature, 6 studies were identified which neonates predicted by PBPK model. mPBPK consisted four physiological parameters; liver kidney weights blood flow these organs. models, values parameters sum then used CL using adult values. was on Age Dependent Exponent (ADE). ADE uses different exponents across age groups. These are 1.2 for 1.1 0-3 months, 1.0, 0.90, 0.75 >3 months-2 years, >2-5 >5 respectively. For prediction from allometry used. compared experimental (clinical) acceptable error within 0.5-1.5-fold. Results: There 26 86 observations. PBPK, mPBPK, 90.7%, 98.8%, 93.0% observations 2-fold error, 81.4%, 84.9% 0.5-2-fold Conclusions: This indicates that models essentially similar drug much easier develop than as accurate robust PBPK.