Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst …
HHS-FDA
Complex generic drug products represent an increasing share of the generic marketplace and may have distinct user interface differences compared to reference listed drug (RLD) products. A modernized …
Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution …
HHS-FDA
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 disper…
Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release …
HHS-FDA
Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged perio…
Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical …
HHS-FDA
The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetyl galactosamine (GalNAc)-conjugated siRNA drug, and to unders…
Competing Revisions to Existing NIH Single Project Research Grants and Cooperative Agreements (Clinical Trial Optional)
HHS-NIH11
The National Institutes of Health (NIH) hereby notifies NIH award recipients that funds may be available for revision applications to support the expansion of existing projects and/or programs within…
Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial …
HHS-FDA
The objective of this research proposal is to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for two major types of long acting in…
Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical …
HHS-FDA
Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clin…
NHLBI Program Project Applications (P01 Clinical Trials Optional)
HHS-NIH11
The National Heart, Lung, and Blood Institute (NHLBI) Program Project Grant (P01) supports research related to fundamental processes and diseases of the heart, blood and lymphatic vessels, lungs, and…
NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Required)
HHS-NIH11
The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, indepen…
NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Basic Experimental Studies …
HHS-NIH11
The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, indepen…
NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Not …
HHS-NIH11
The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, indepen…
National Institute of General Medical Sciences Predoctoral Basic Biomedical Sciences Research Training Program (T32)
HHS-NIH11
The goal of the NIGMS Predoctoral Basic Biomedical Sciences Research Training Program is to develop a pool of well-trained scientists available to address the Nations biomedical research agenda. Spec…