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. Resu...
Source: NIH Funding Opportunities (Notices, PA, RFA) - April 2, 2014 Category: Research Source Type: funding
Evaluation of in vitro release methods for liposomal drug products
This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products.
Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following:
a. Review available in vitro release methods for the selected model liposomal drug product(s).
b. Prepare a series of liposome formulations with similar formulation composition to the marketed model product but with different process conditions. ...
Source: Grants.gov - March 31, 2014 Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding
