The initiatives for regulatory science researches of nanomedicines

Abstract

Nanomaterials often have physical, chemical, or biological properties that are different from those of bulk materials. These properties may have potential impacts on a variety of products, and nanotechnology application to pharmaceuticals is a typical such example. Because the unique size-specific interaction with biological systems or biodistribution may have significant impacts on the efficacy and safety of nanomedicines, regulatory science researches of nanomedicines are required. We have been conducting the formulation study, and nonclinical pharmacokinetics, pharmacodynamics, toxicology, and clinical studies of the polymeric micelles and lipid nanoparticles which are designed to ensure high stability in vivo and to optimize the pharmacokinetics. In this review, we introduce our initiatives for regulatory science researches of nanomedicines.