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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
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.
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.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $250,000
Office: Food and Drug Administration
Estimated Funding: $250,000
Who's Eligible
Obtain Full Opportunity Text:
NSF Publication 24-526
Additional Information of Eligibility:
Eligible Applicants: Eligibility is limited to the alumni of U. S. government-sponsored exchange programs, who are citizens or residents of Georgia.
(https://alumni.state.gov/list-exchange-programs) Other Eligibility Requirements: Applicants are only allowed to submit a maximum of two proposal per individual.
If more than two proposals is submitted from an individual, all proposals from that individual will be considered ineligible for funding.
If a group of alumni cooperate to submit a joint project, the requested amount cannot exceed $20,000.
The submitting applicant should be an individual alumnus/alumna or the group of alumni, but the grant can be awarded to the organization partnering in the project.
If the organization will be the awardee, they need to present active SAM.gov registration prior to awarding process.
SAM.gov registration for applicant individuals is not required.
Full Opportunity Web Address:
http://www.nsf.gov/publications/pub_summ.jsp?ods_key=nsf24526
Contact:
Agency Email Description:
terrin.brown@fda.hhs.gov
Agency Email:
Date Posted:
2024-01-15
Application Due Date:
Archive Date:
2024-04-30
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