Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitr
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
| Agency | Food and Drug Administration |
|---|---|
| Status | Forecasted |
| Opportunity number | FOR-FD-24-005 |
| Posted date | 11/24/2023 |
| Award ceiling | 500,000 |
| Award floor | 250,000 |
| Expected number of awards | 2 |
| Who can apply | Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmiss |
| Assistance Listing (CFDA) | 93.103 |
| 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 |
| Agency contact | terrin.brown@fda.hhs.gov |
| Official listing | https://www.grants.gov/search-results-detail/351127 |