Publication / Source: International Journal of Pharmacokinetics 2(2)
Authors: Cole S, Hay JL, Luzon E, Nordmark A & Rusten IS
Physiologically based pharmacokinetic (PBPK) models offer a mechanistic understanding of the disposition of the drug in the body. When well informed and conducted, this may lead to more efficient clinical studies in the vulnerable pediatric population. A review of pediatric submissions to European regulatory authorities has shown a limited number of recent examples.