Evaluation of In Vitro Release Methods for Liposomal Drug Products (U01)

This study aims to evaluate different in vitro release assays in terms of their capacity in detecting formulation differences and predicting in vivo release of liposomal drug products. Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, we expect a grantee to conduct in vitro release studies under multiple conditions, perform in vivo pharmacokinetics and biodistribution studies in animal model, collect literature report on human pharmacokinetics data, and establish an in silico platform to explore the in vivo in vitro correlation of liposomal drug products. Results from this study will advance the regulatory review process and ultimately improve public access to quality generic liposomal drug products.
Source: NIH Funding Opportunities (Notices, PA, RFA) - Category: Research Source Type: funding