Using PK/PD M&S for Pediatric Drug Development: Regulatory Insights into Practical Issues скачать в хорошем качестве

Using PK/PD M&S for Pediatric Drug Development: Regulatory Insights into Practical Issues

Pediatric drug development continues to be a vexing challenge, yet pediatric research is increasingly being mandated by regulators and patients alike. Traditional clinical trials can be problematic for ethical and logistical reasons. Children are a challenging population, especially neonates and infants, as organ maturation affects drug exposure and response. Pharmacokinetic (PK)- and pharmacokinetic/pharmacodynamic (PK/PD)-modeling and simulation (M&S) plays an ever more crucial role in pediatric drug development. The usefulness of M&S in pediatric drug development includes clinical trial simulation, dose selection, choice and optimization of study design, endpoint selection, and extrapolation. With the greater importance placed on pediatric trials and the data obtained from them, this webinar addressed some of the challenges associated with pediatric drug development and the advantages (and limitations) that pediatric population PK modeling can provide. Our speakers, Drs. Nastya Kassir and Justin Pittaway-Hay provided an overview of the regulatory perspectives into common issues that are raised during regulatory submissions of M&S data for pediatric populations. Please visit us at https://www.certara.com