Systemic Bioequivalence Is Unlikely to Equal Target Site Bioequivalence for Nanotechnology Oncologic Products

Au, JLS; Lu, Z; Abbiati, RA; Wientjes, MG

Au, JLS (reprint author), Inst Quantitat Syst Pharmacol, 1815 Aston Ave,Suite 107, Carlsbad, CA 92008 USA.; Au, JLS (reprint author), Optimum Therapeut LLC, Carlsbad, CA 92008 USA.; Au, JLS (reprint author), Univ Oklahoma, Dept Pharmaceut Sci, Oklahoma Ci

AAPS JOURNAL, 2019; 21 (2):

Abstract

Approval of generic drugs by the US Food and Drug Administration (FDA) requires the product to be pharmaceutically equivalent to the reference listed ......

Full Text Link