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
Description
This grant opportunity aims to study the effectiveness of an in vitro gastrointestinal dissolution model to evaluate amorphous solid dispersion (ASD) drug products. The focus is on understanding how food and acid-reducing agents affect drug absorption, considering different formulations of drugs. By refining and validating this methodology, it seeks to predict in vivo outcomes and guide the requirements for bioequivalence studies. The ultimate goal is to improve regulatory decisions and redu…
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 dev…
Source
Grant ID
FOR-FD-24-005
Funding Source
Food and Drug Administration
Eligibility
The following categories of applicants are invited to apply:
- Native American tribal governments (Federally recognized)
- City or township governments
- Independent school districts
- Native American tribal organizations (other than Federally recognized tribal governments)
- Public housing authorities/Indian housing authorities
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- For profit organizations other than small businesses
- Small businesses
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Special district governments
- County governments
- State governments
- Public and State controlled institutions of higher education
- Private institutions of higher education
Awards & Funding
Award Ceiling
$500,000
Award Floor
$250,000
Funding Amount
Discretionary
Links
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