2014
DOI: 10.1016/j.jconrel.2014.06.005
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Issues and concerns in nanotech product development and its commercialization

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Cited by 94 publications
(48 citation statements)
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“…Several specific safety issues can affect this process, primarily pertaining to: 1) the set-up and validation of standardized in vitro assays, with suitable reference materials; 2) the development of ex vivo/ in vivo models relevant for the route of administration; 3) the generation of in silico approaches which are predictive for biological and toxicological responses; and 4) in vivo pharmacokinetic studies. 25 Finally, the interactions of NMbased medicines with the major biological systems deserve particular attention from coordinated contributions of multidisciplinary competences. …”
Section: Regulatory Issuesmentioning
confidence: 99%
“…Several specific safety issues can affect this process, primarily pertaining to: 1) the set-up and validation of standardized in vitro assays, with suitable reference materials; 2) the development of ex vivo/ in vivo models relevant for the route of administration; 3) the generation of in silico approaches which are predictive for biological and toxicological responses; and 4) in vivo pharmacokinetic studies. 25 Finally, the interactions of NMbased medicines with the major biological systems deserve particular attention from coordinated contributions of multidisciplinary competences. …”
Section: Regulatory Issuesmentioning
confidence: 99%
“…The National Nanotechnology Initiative and ASTM International have defined nanotechnology as a term that refers to technologies that manufacture and manipulate materials with a dimension between 1 and 100 nm to exploit their novel properties. They are expanding the design, characterization, synthesis, limitations, toxicity, and applications of nanomaterials (Khajeh et al, 2013;Kaur et al, 2014). Further, nanostructure is defined as a specified structural object with development of resistance (Pelgrift and Friedman, 2013;Leid et al, 2012).…”
Section: Introductionmentioning
confidence: 99%
“…, Doxil, Abraxane, and Genexol) have been approved by the regulatory agencies to treat cancer patients. 10 …”
Section: Introductionmentioning
confidence: 99%