2024
DOI: 10.1002/cpt.3366
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New Horizons of Model Informed Drug Development in Rare Diseases Drug Development

Amitava Mitra,
Nessy Tania,
Mariam A. Ahmed
et al.

Abstract: Model‐informed approaches provide a quantitative framework to integrate all available nonclinical and clinical data, thus furnishing a totality of evidence approach to drug development and regulatory evaluation. Maximizing the use of all available data and information about the drug enables a more robust characterization of the risk–benefit profile and reduces uncertainty in both technical and regulatory success. This offers the potential to transform rare diseases drug development, where conducting large well… Show more

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