Stephan T Stern
Nanotechnology Characterization Lab, USA
Title: Challenges in evaluation of nanomedicine pharmacokinetics and generic bioequivalence
Biography
Biography: Stephan T Stern
Abstract
The success of nanomedicine (NM) drug delivery platforms relies upon their ability to influence drug disposition. Therefore, pharmacokinetic evaluation of NM is crucial to optimizing formulation properties and understanding how these properties result in therapeutic benefit. Comprehensive pharmacokinetic evaluation of NM requires quantification of several drug species, including NM encapsulated and encapsulated drug, and in some cases free and protein bound forms of the encapsulated drug as well. Indeed, the pharmacokinetic complexity of NM adds substantial difficulties to traditional pharmacokinetic and bioequivalence studies. This presentation will address the importance and challenges of monitoring the disposition and in vivo integrity of nanotechnology platforms, highlighting potential problems with current bioanalytical techniques, and introducing a new stable isotope tracer methodology currently under evaluation through a partnership between the FDA and NCI.