IQ CPLG Pediatrics Working Group Publishes in CPT on Key Area for Pediatrics Product Development
The IQ Clinical Pharmacology Leadership Group's Pediatric Working Group has published "Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of Extrapolation" in The Clinical Pharmacology & Therapeutics Journal.
Extrapolation can be used to address challenges in pediatric drug development. This review describes how these challenges could be addressed by further evolution of quantitative frameworks (i.e., model-based/informed drug discovery and development) and regulatory science in support of pediatric drug development. Included are examples of diseases/indications where extrapolation has been used in different ways as a basis for identifying gaps in the framework and opportunities for continued advancement of pediatric drug development.
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