Offer an extensive overview of pediatric clinical pharmacology and the associated regulatory and ethical challenges in developing medicines for children. The text details the developmental changes in pediatric physiology that impact drug disposition (pharmacokinetics and pharmacodynamics), from preterm infants through adolescence, emphasizing the necessity of age-appropriate dosing and formulations. Discussions also cover clinical trial design for small and vulnerable pediatric populations, including strategies to minimize sample sizes and the role of modeling and simulation (M&S), as well as the importance of therapeutic drug monitoring (TDM). Finally, the material examines the legislative frameworks (US and EU), ethical considerations for research with children, and global efforts to improve access to essential pediatric medicines.
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