Pediatric pharmacodynamics: Developmental Impact on Drug Effects and Safety

Supported by the latest ICH guideline, pediatric extrapolation is crucial for the development, authorization, and clinical informed use of pediatric drugs. While extrapolation of pharmacokinetics already has a well-established track record in pediatric drug development, there is still a knowledge gap on developmental pharmacodynamics, including developmental safety aspects. The (dis)similarities in drug effects and safety are informed by exposure (pharmacokinetics), but necessitates a better understanding of drug targets (including off-target effects) during normal development and in disease conditions. To facilitate this, we need validation of endpoints throughout childhood to be used to measure effects or safety endpoints, and need to share sources and existing datasets. Early infancy, physical growth, and neurobehavioral development, or puberty serve as illustrations of specific settings. Modeling and simulation are very useful tools in drug development to verify potential pediatric extrapolation during drug development.This Research Topic aims to examine the impact of maturation on developmental changes in pharmacodynamics, including drug and side effects, that should be considered for pediatric extrapolation. Additionally, this Research Topic aims to improve our understanding of the use of modeling and simulation tools that may facilitate the advancement of pediatric extrapolation in clinical pharmacology.We therefore welcome original research, systematic or narrative reviews, or position papers that assist the community to improve pediatric drug development and pharmacotherapy.Topic Editor Catherine Sherwin is employed by Differentia Biotech. All other Topic Editors declare no competing interests with regards to the Research Topic subject. Topic editors: Sílvia M Illamola, Kathleen M Job, Karel Allegaert, Catherine M T Sherwin Source: https://www.frontiersin.org/research-topics/79153/pediatric-pharmacodynamics-developmental-impact-on-drug-effects-and-safety