Description of Collaborative Activity: |
This IAA is a collaboration between NICHD and the Center for Drug Evaluation and Research, FDA. The purpose is to create an open-source, publicly available oral pediatric formulations platform. This platform will designate specific formulation technologies, given the molecular and chemical properties of the drug and specific desired properties of the dosage form. The ideal pediatric dosage form would be an orally dissolvable solid; tasteless; in an appropriate dose amount that would be appropriate for infants; contain minimal amounts of safe excipients; stable in light, humidity, and heat; and have the necessary release characteristics, as applicable. |
