Clinical Trials

The NANOLEK strategy provides for conducting studies on new drugs in Russia, both innovative and biosimilar, which are newly introduced to the Russian market. The NANOLEK team has successfully completed clinical trials of the first inactivated polio vaccine for children and adults, about 10 bioequivalence studies and carries out researches of a number of biosimilar products, including monoclonal antibodies.

The development of design and clinical trials reports that meet international standards on the one hand and domestic recommendations on the other is the main focus of the medical department. While planning researches, we are guided by the current recommendations for the study of generic, biosimilar and innovative products such as ICH, EMA, FDA, Russian legislation requirements, and use modern statistical methods and approaches to the evaluation of the effect of a particular drug. A number of studies, particularly on biologic drugs and vaccines, require an individual approach and cooperation with the key Russian research centers.

Clinical trials of drugs produced by NANOLEK pass multistage quality control at all stages: starting from creating the centers to their closing and statistical data processing. This guarantees high quality, safety and efficiency of drugs entering the Russian market.


For cooperation on clinical studies, please contact the NANOLEK Medical Department - med@nanolek.ru.