Prediction of Drug Concentration-Time Profiles in Children From Adults: An Allometric Approach

摘要

The main objective of this work was to evaluate 2 methods to predict concentration-time profiles of drugs in children (aged 5 years or older) from adult pharmacokinetic (PK) parameters. Five drugs from the literature were chosen for this study, and all these 5 drugs were described by a 2-compartment model in both adults and children. PK parameters (CL, V-c, V-ss, and V) were allometrically predicted in children from adults. PK constants such as A, B, , and were also predicted in children from adults as described in Appendix 1. Using predicted PK parameters and constants, concentration-time profiles of 5 drugs were predicted in children and compared with the observed profiles. Both methods of predictions provided fairly good prediction of concentration-time profiles in children. The predicted concentration-time profiles in children were comparable with the observed profiles and can be used to design first-in-children clinical trials.