Nanoscale Therapeutic System: Safety Assessment Features

Nanoscale drugs differ in special physicochemical, biological, pharmacokinetic parameters. These properties can be used to provide targeted delivery, prolong the action of drugs, as well as reduce their side effects. An important problem that needs attention is the study of the potential risks arising from the treatment of such drugs. The aim of the study: analysis of the requirements of domestic and foreign regulators for the safety of nanoscale drugs. The paper presents the classification of the most promising nanosystems containing drugs, and an analysis of the existing principles for assessing their safety in Russia and abroad has been carried out. It was shown that when assessing the safety of nano-sized drugs, along with the properties of the active substance, it is necessary to take into account the properties of the nanosystem (polymer coating, carrier, etc.), related to its size, distribution pattern, charge of nanoparticles, and ability to induce oxidative stress. Domestic and foreign regulatory documents governing the procedure for assessing the safety of pharmacological substances derived from nanotechnology was analyzed. Conclusions: Despite the availability of recommendations from regulatory authorities, further improvement of the requirements for registration and safety assessment of nanoscale drugs is necessary. Further development of the regulatory framework governing the development, quality, efficiency and safety of nanomaterials in medicine is necessary, taking into account the structural issues of the active substance and nano-carriers.

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