ROS comprise hydroxyl radicals, superoxide anion and hydrogen peroxide.

J. Pharm.

J. Intern. After a nanomedicine obtains the marketing authorization, there is a long way up to the introduction of the nanomedicine in the clinical practice in all EU countries. The first one is related to the physiopathological nature of the diseases. Biophys. Nanomedicines in the EU—regulatory overview.

One of the most important interactions with the living matter relies on the plasma/serum biomoleculeadsorption layer, known as “corona,” that forms on the surface of colloidal nanoparticles (Pino et al., 2014). Int. Over the last years, nanotechnology has been introduced in our daily routine. 1, 660–670. Biocompatibility and nanostructured materials: applications in nanomedicine. He promulgated a categorization of mind and matter as composed of eight types of “kalapas” of which the four elements are primary and a secondary group of four are color, smell, taste, and nutriment which are derivative from the four primaries. Environ. Winkler, D. A., Mombelli, E., Pietroiusti, A., Tran, L., Worth, A., Fadeel, B., et al. J. Med. Annu. Pre-clinical assessment of nanomaterials involve a thorough biocompatibility testing program, which typically comprises in vivo studies complemented by selected in vitro assays to prove safety. By the time of Antoine Lavoisier, for example, a list of elements would no longer refer to classical elements.

doi: 10.1016/j.biomaterials.2007.12.037, Desai, N. (2012). Moreover, they are less time consuming, more cost-effective, simpler and provide an easier control of the experimental conditions (Kroll et al., 2009; Fadeel et al., 2013b). (2014). Pharmacol. (2018). Nanotechnol. doi: 10.1038/nnano.2016.232, Keywords: nanotechnology, nanomedicine, nanomaterials, pharmaceutical development, nanotoxicology, Citation: Soares S, Sousa J, Pais A and Vitorino C (2018) Nanomedicine: Principles, Properties, and Regulatory Issues. Currently, EUnetHTA is developing the Joint Action 3 until 2020 and the main aim is “to define and implement a sustainable model for the scientific and technical cooperation on Health Technology Assessment (HTA) in Europe.”. The maximum size that a material can have to be considered nanomaterial is an arbitrary value because the psychochemical and biological characteristics of the materials do not change abruptly at 100 nm. 32, 711–726. Rev.

450 BC) proved (at least to his satisfaction) that air was a separate substance by observing that a bucket inverted in water did not become filled with water, a pocket of air remaining trapped inside. Nanomedicine comprises both biological and non-biological medical products. Furthermore, optical, electrical and magnetic properties can change and be tunable through electron confinement in nanomaterials.

N. Y. Acad. These different cultures and even individual philosophers had widely varying explanations concerning their attributes and how they related to observable phenomena as well as cosmology. (2017).

The EMA working group introduces nanomedicines as purposely designed systems for clinical applications, with at least one component at the nanoscale, resulting in reproducible properties and characteristics, related to the specific nanotechnology application and characteristics for the intended use (route of administration, dose), associated with the expected clinical advantages of nano-engineering (e.g., preferential organ/tissue distribution; Ossa, 2014).


Luxembourg: Publications Office of the European Union; Joint Research Centre Reference of the European Commission. QSAR models are based on the hypothesis that the toxicity of nanomaterials and their cellular fate in the body can be predicted by their characteristics, and different biological reactions are the result of physicochemical characteristics, such as size, shape, zeta potential, or surface charge, etc., gathered as a set of descriptors. Studies are required to address how nanomaterials penetrate cells and tissues, and the respective biodistribution, degradation, and excretion.



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