forecasted
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
Food and Drug Administration · FOR-FD-24-005
$250,000 – $500,000
Not specified
City or township governments, Public and State controlled institutions of higher education, Native American tribal organizations (other than Federally recognized tribal governments), Private institutions of higher education, County governments, State governments, Native American tribal governments (Federally recognized), Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Others (see text field entitled "Additional Information on Eligibility" for clarification), Special district governments, Small businesses, Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility", Independent school districts, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, For profit organizations other than small businesses, Public housing authorities/Indian housing authorities
Geographic eligibility and all attachment-specific conditions require review of the original announcement.
Eligibility details
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 resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Matching funds & resources
Source matching-funds field: Not Required.
Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.
About this opportunity
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.
Funding geography: Not specified — review source. A funder’s address does not establish eligibility.
Review original source ↗Funding instrument: Cooperative Agreement. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.
Source fields and evidence
id: 351127
Source ↗ · id
opportunityNumber: FOR-FD-24-005
Source ↗ · opportunityNumber
opportunityTitle: 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
Source ↗ · opportunityTitle
revision: 1
Source ↗ · revision
agencyDetails: {"code":"FDA","seed":"HHS-FDA","agencyName":"Food and Drug Administration","agencyCode":"HHS-FDA","topAgencyCode":"HHS"}
Source ↗ · agencyDetails
owningAgencyCode: HHS-FDA
Source ↗ · owningAgencyCode
cfdas: [{"id":415635,"opportunityId":351127,"cfdaNumber":"93.103","programTitle":"Food and Drug Administration Research"}]
Source ↗ · cfdas
forecastDesc: <p><span style="color: black;">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. </span></p>
Source ↗ · forecastDesc
applicantTypes: [{"id":"02","description":"City or township governments"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"20","description":"Private institutions of higher education"},{"id":"01","description":"County governments"},{"id":"00","description":"State governments"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"04","description":"Special district governments"},{"id":"23","description":"Small businesses"},{"id":"99","description":"Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled \"Additional Information on Eligibility\""},{"id":"05","description":"Independent school districts"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"08","description":"Public housing authorities/Indian housing authorities"}]
Source ↗ · applicantTypes
applicantEligibilityDesc: 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 resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Source ↗ · applicantEligibilityDesc
fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
Source ↗ · fundingInstruments
fundingActivityCategories: [{"id":"AG","description":"Agriculture"},{"id":"CP","description":"Consumer Protection"},{"id":"FN","description":"Food and Nutrition"}]
Source ↗ · fundingActivityCategories
awardFloor: 250000
Source ↗ · awardFloor
awardCeiling: 500000
Source ↗ · awardCeiling
costSharing: false
Source ↗ · costSharing
lastUpdatedDate: Nov 30, 2023 03:59:15 PM EST
Source ↗ · lastUpdatedDate
status: forecasted
Source ↗ · oppHits[id=351127].oppStatus
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