Designing a paediatric study for an antimalarial drug including prior information from adults
A pharmacokinetic (PK) study in children was designed using prior information: PK data for adults and children were available from two different randomised studies for treatment of malaria with the same artesunate-mefloquine combination regimen. A recommended design for paediatric study on mefloquine was optimised based on an extrapolated model built from adult data. Pharmacokinetic parameters were well estimated with low relative standard errors. 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. It is concluded that using prior adult information combined with allometry and maturation can help provide robust designs for paediatrics studies.
Petit, C.; Jullien, V.; Samson, A.; Guedj, J.; Kiechel, J.R.; Zohar, S.; Comets, E. Designing a paediatric study for an antimalarial drug including prior information from adults. Antimicrobial Agents and Chemotherapy (2015) : [DOI: 10.1128/AAC.01125-15]