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
About This Grant
<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>
Grant Summary
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 is a Food and Drug Administration grant providing $250K to $500K for tribal government, university, small business. Applications are accepted on a rolling basis. Check eligibility and apply with FindGrants.
Focus Areas
Eligibility
- 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).
How to Apply
$250K–$500K
Rolling / Open
- 1Confirm your organization is eligible for 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 from Food and Drug Administration, checking organization type, location, and any population or project requirements.
- 2Gather the required documents and information, including your organization details, project plan, and budget figures.
- 3Draft your application narrative and budget addressing the funder's priorities and review criteria. FindGrants can draft each section for you to review and edit.
- 4Review every section against the requirements checklist, then export a submission-ready application pack and submit it to Food and Drug Administration before the deadline.
Search & build free — $99 one-time to unlock the export-ready application pack. No subscription.
Don't want to draft it yourself?
We'll draft the complete application against Food and Drug Administration's requirements, run a quality review, and email you a submission-ready PDF plus an editable Word doc within 5 business days. Most orders deliver in 24-48 hours. Flat $399, any grant size.
AI Requirement Analysis
Detailed requirements not yet analyzed
Have the NOFO? Paste it below for AI-powered requirement analysis.
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: Frequently Asked Questions
Who is eligible for the 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?
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 is offered by Food and Drug Administration and is generally open to tribal government, university, small business, municipality, nonprofit, healthcare org, school district. It is open to organizations nationwide unless the funder specifies otherwise. Review the specific eligibility terms before applying, since funders set their own requirements around organization type, location, and the population or project being served.
How much funding does the 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 provide?
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 provides between $250K and $500K per award from Food and Drug Administration. Actual award sizes depend on the scope of your project, available program funds, and the number of applicants, so build a budget that reflects realistic, allowable costs rather than the maximum figure.
When is the 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 deadline?
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 accepts applications on a rolling or ongoing basis, so there is no single fixed deadline. Confirm current timing with the funder, Food and Drug Administration, before you apply, and submit as early as possible because rolling programs can close once funds are committed.
How do you apply for the 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?
To apply for 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, confirm your eligibility, gather the required documents, and prepare a narrative and budget that address the funder's priorities. FindGrants guides you step by step and can draft each section, then exports a submission-ready application pack for this grant from Food and Drug Administration.