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  NIH: Evaluation of In Vitro Release Methods for Liposomal Drug Products (U01)RFA-FD-14-016

The development of generic liposomal drug products face challenges because of a lack of compendial or bio-relevant in vitro release methods. These challenges contribute to the limited access to essential medicines in many countries. 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.

USC may only submit one application in response to this program announcement. Your application submission MUST be coordinated with the Office of the Vice President for Research. Please send a two page abstract via email to Richard White ( by May 2, 2014. In addition to the 2-page abstract, you should also submit a biosketch for the PI.

NIH indicates that a letter of intent is Not Applicable and a full proposal is due by June 1, 2014. For more information:
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