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

Summary

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.

Eligibility

• Native American Tribal Organizations Other Than Federally Recognized Tribal Governments
• Public and State Institutions of Higher Education
• For Profit Organizations Other Than Small Businesses
• Native American Tribal Governments Federally Recognized
• State Governments
• Unrestricted
• Special District Governments
• County Governments
• Nonprofits Non Higher Education Without 501c3
• Private Institutions of Higher Education
• Nonprofits Having A 501(c)(3) Status With the Irs Other Than Institutions of Higher Education
• Independent School Districts
• City Or Township Governments
• Small Businesses
• Public and Indian Housing Authorities
• Other

Funding categories

• Consumer Protection
• Agriculture
• Food and Nutrition