Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development: A Clinician’s Request for a More Integrated Approach

Figure 1

Integration of in vivo datasets analyzed by mechanism-based and PBPK predictive models results in a switch from “explorative, hypothesis-driven” to “confirmative” approach in the field of developmental physiology. This is illustrated for renal drug clearance in neonates, which reflects glomerular filtration rate (e.g., aminoglycosides) or a more complex pattern of known (glomerular filtration rate, protein binding) and still unknown (renal tubular transport ontogeny) (e.g., cefazolin) maturational processes.