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Moxifloxacin is a widely used fluoroquinolone for the treatment of complicated intra‐abdominal infections. We applied physiologically‐based pharmacokinetic ( PBPK ) and population pharmacokinetic (pop PK ) modeling to support dose selection in pediatric patients. We scaled an existing adult  PBPK  model to children based on prior physiological knowledge. The resulting model proposed an age‐dependent dosing regimen that was tested in a phase I study. Refined doses were then tested in a phase  III  study. A pop PK  analysis of all clinical pediatric data confirmed the  PBPK  predictions, including the proposed dosing schedule in children, and supported  pharmacokinetics ‐related safety/efficacy questions. The pediatric  PBPK  model adequately predicted the doses necessary to achieve antimicrobial efficacy while maintaining safety in the phase I and  III  pediatric studies. Altogether, this study retroactively demonstrated the robustness and utility of modeling to support dose finding and confirmation in pediatric drug development for moxifloxacin.

cpt: pharmacometrics and systems pharmacology

Application of Physiologically‐Based and Population  Pharmacokinetic  Modeling for Dose Finding and Confirmation During the Pediatric Development of Moxifloxacin