title: What is unique about nanomedicine? The significance of the mesoscale.
abstract: Unlike drugs and medical devices, for which long standing and continuously improving quality assurance/quality control infrastructures exist, many nano-based products lack well-defined standards that are useful to manufacturers and regulators. Inherent variabilities in nanoparticle sizes and shapes, their large surface-to-volume ratios, and their mesoscale interactions with subcellular structures, suggest new complexities and challenges that must be met before widespread application of nanomedicines can be expected.
authors.affiliation: Department of Philosophy, Center for Bioethics at the University of South Carolina, SC, USA.
authors.forename: George
authors.initials: G
authors.lastname: Khushf
authors.forename: Ronald A
authors.initials: RA
authors.lastname: Siegel
mesh_terms: D018795:Device Approval; D017277:Drug Approval; D033161:Government Regulation; D006801:Humans; D050997:Nanomedicine / Q000941:ethics / Q000331:legislation & jurisprudence*; D049329:Nanostructures / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D012308:Risk Management / Q000941:ethics / Q000331:legislation & jurisprudence; D009626:Terminology as Topic; D014481:United States