Simpler Grants.gov #FOR-FD-24-005

FDA Solicits Research on In Vitro GI Dissolution Models for High-Risk Oral Drug Products

The Food and Drug Administration (FDA) is seeking research partners to advance the predictability of food-drug and drug-drug interaction risks for high-risk oral drug products using in vitro gastrointestinal (GI) dissolution models. - Government Buyer: - Food and Drug Administration (FDA) - Products/Services Requested: - Research and development services focused on: - Developing and validating mechanistic methodologies for in vitro GI dissolution models - Assessing performance of amorphous solid dispersion (ASD) drug products under clinically relevant conditions - Correlating in vitro results with in vivo outcomes - Defining bioequivalence study requirements and informing regulatory decisions - Unique/Notable Requirements: - Methodology must address the impact of food and acid reducing agents on drug absorption - Research should support regulatory decisions for high-risk generic oral drug products - Open to a wide range of applicants, including nonprofits, educational institutions, businesses, and government entities - OEMs and Vendors: - No specific OEMs or vendors are named in this opportunity - Funding Details: - Cooperative agreement with awards ranging from $250,000 to $500,000

Description

This funding opportunity aims to examine the utility of an in vitro simulated gastrointestinal dissolution model to assess the performance of amorphous solid dispersion drug products under various clinically relevant conditions. The goal is to develop and validate a mechanistic methodology that improves understanding of the impact of food and acid reducing agents on drug absorption for test and reference listed drug products. The methodology is intended to correlate in vitro observations with in vivo outcomes, define necessary bioequivalence studies, and inform regulatory decisions to mitigate risks for high-risk generic oral drug products.

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