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. 

Nonprofit

• Other Native American tribal organizations
• Nonprofits non-higher education without 501(c)(3)
• Nonprofits non-higher education with 501(c)(3)

Education

• Public and state institutions of higher education
• Private institutions of higher education
• Independent school districts

Business

• For-profit organizations other than small businesses
• Small businesses

Government

• Federally recognized Native American tribal governments
• State governments
• Special district governments
• County governments
• City or township governments
• Public and Indian housing authorities

Miscellaneous

• Unrestricted
• Other