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Updated: Feb 16, 2026

ALS - Motor Neuron Disease: Mechanism and Development of New Therapies
Published on: July 29, 2007
Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of
Jeffrey S Barrett1, Raafat Bishai2, Christina Bucci-Rechtweg3
1Translational Medicine, Translational Informatics, Sanofi, Bridgewater, New Jersey, USA.
Abstract:
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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