Dose optimization is critical in pediatric medicines development to ensure that a safe and efficacious dose is correctly administered to children. Variability in the pediatric population by size and/or age can alter exposure and subsequently the desired response. Understanding how to select the ideal pediatric dose can be accomplished by leveraging existing data, employing dose-finding study designs that maximize small sample sizes, utilizing quantitative approaches, and employing simulations to maximize the probability of the administration of a safe and effective dose of new pediatric medicines. This EFGCP workshop has been designed to provide an opportunity to actively engage with experts on the fundamentals of developing a strategy for pediatric dose optimization. #pediatrics, #children, #pharmacokinetics, #pharmacodynamics, #regulatory, #clinicaltrials, #dose, #optimization
📢 The EFGCP Better Medicines for Children Virtual Pre-Conference 2023 will take place in a month, register now and join us for a half-day of intense discussions and case studies on Pediatric Dose Optimization! #Pediatric #Dose #Optimization 12 Oct. 2023 | Half Day Virtual Meeting | Zoom Dose optimization is integral to maximizing pediatric medicines development. Variability in #pharmacokinetic and #pharmacodynamic parameters across the pediatric population by size and/or age can increase the complexity associated with identifying the optimized dose for use of a new medicine. Understanding how to design and optimize selection of a pediatric dose leveraging existing data, employing dose-finding designs that maximize small patient numbers, or utilize quantitative approaches, is essential to maximizing safety, effectiveness and tolerability of new pediatric medicines. This workshop has been designed to provide pediatric #researchers, trial #sponsors, and #regulatory reviewers an opportunity to actively engage with experts on the fundamentals of developing a #strategy for pediatric dose optimization. Attendees will participate in interactive small group discussions utilizing case examples. Experts will guide attendees through the development of an anonymized pediatric dosing strategy utilizing two case examples – determining the relevance of available data for use in the pediatric program design, analysing whether model-informed approaches are appropriate, and/or evaluating and proposing study designs. More information and registration: https://lnkd.in/eti2S4kV #children #medicines #paediatrics #clinicaltrials
