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Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional

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Contract Overview

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AI Contract Overview

The Food and Drug Administration, under the Department of Health and Human Services, is seeking to develop and validate an in vitro simulated gastrointestinal dissolution model to assess the performance of amorphous solid dispersion drug products. This initiative aims to analyze how food and acid reducing agents impact the absorption of test and reference listed drug products, accounting for variations in formulation and manufacturing. The primary objective is to create a bio predictive mechanistic methodology that correlates in vitro observations with in vivo outcomes. This data will be used to determine the necessary bioequivalence studies for these drug products and to inform regulatory decisions aimed at reducing the risk of failure in achieving therapeutic equivalence for high risk generic oral medications.

General Info

Develop in vitro gastrointestinal model to predict oral drug performance with food and acid-reducing agents.

Agency

Department Of Health And Human Services → Food And Drug Administration

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

No documents available

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Timeline

PostedNov 24

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → Food And Drug Administration

Contacts1 person available

OfficeUSA

Organization / Agency

Department Of Health And Human Services → Food And Drug Administration

Office AddressUSA

Contacts

Terrin Brown Grantor

contact@example.gov

+1 (555) 000-0000

Full Description

The purpose of this funding opportunity is to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions. The goal is to develop and validate the in vitro mechanistic methodology to provide an improved understanding of impact of food and acid reducing agents on the absorption for test and reference listed drug (RLD) drug products, taking into consideration their potentially different formulations and manufacturing. The bio predictive in vitro mechanistic methodology is intended to correlate the in vitro observations to in vivo outcomes, help define types of in vivo bioequivalence (BE) studies needed for ASD drug products, and inform regulatory decision-making related to mitigating the risk of potential failure modes for therapeutic equivalence for high-risk generic oral drug products.