NCL’s Sr. Principal Scientist in Pharmacology & Toxicology, Dr. Stephan Stern, has spearheaded several important publications on the complexity of nanomedicine pharmacokinetics and the importance of measuring all drug fractions—nanomedicine encapuslated, protein-bound, and free unbound drug—when evaluating nanomedicine PK. The most recent of these publications is entitled “When Is It Important to Measure Unbound Drug in Evaluating Nanomedicine Pharmacokinetics?”, co-authored with Marilyn Martinez from the US FDA and NCL formulation scientist David Stevens. Read the Drug Metabolism and Disposition article here: http://dmd.aspetjournals.org/content/44/12/1934.long
Other recent publications on this topic include:
Stable isotope method to measure drug release from nanomedicines.
Skoczen, S., S.E. McNeil, and S.T. Stern
J Control Release, 2015, 220(Pt A), 169-174.
NBCD Pharmacokinetics and bioanalytical methods to measure drug release.
Ambardekar, V.V.; Stern, S.T.,
Non-Biological Complex Drugs; The Science and the Regulatory Landscape, Crommelin, D.J.A., de Vlieger J.S.B, Editors.
Springer International Publishing, 2015, 261-287.