Designing a pediatric study for an antimalarial drug by using information from adults

by Petit C, Jullien V, Samson A, Guedj J, Kiechel JR, Zohar S, Comets E. Antimicrobial Agents Chemotherapy 2015. 60(3):1481-91. doi: 10.1128/AAC.01125-15.

Summary: The aims of this study was to design a pharmacokinetic (PK) study by using information about adults and to evaluate the robustness through a case study of mefloquine. PK data on adults and children from two studies using artesunate-mefloquine was used. Although the extrapolated model did not predict the observed mefloquine concentrations in children very accurately, it allowed precise and unbiased estimates across various model assumptions, contrary to the empirical design. Using information from adult studies combined with allometry and maturation can help provide robust designs for pediatric studies.

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