Using PBPK for a Formulation Change for Pediatric Patients (Tablet to Suspension)
Children are not small adults, and not all children are the same. Growth, maturation and environmental factors, along with factors around the disease and genetics, directly affects drug performance in children, especially in small children less than two years of age.
Physiological based pharmacokinetic modeling and simulation (PBPK) has been increasingly applied in pediatric drug development. This is encouraged by regulators. Medicines for children must be well explored and safe, while avoiding any unnecessary clinical testing. It is important to take advantage of all existing information to develop these drugs and these new formulations, while optimizing them for these different age groups.