Center of drug development
The key activities of scientific department of the Institute are research of original drugs and development of medicinal preparations from the List of strategically important drugs, the manufacturing of which has to be provided on the territory of Russia, approved by the Order of the Government of the Russian Federation dated 6 July 2010 N 1141-р.
The whole cycle of drugs’ research and development is implemented:
- development of composition and technology of obtaining, scientific and technical documentation and methods of quality control of medicines;
- examination of scientific and technical documentation;
- conducting of drugs’ Quality Control;
- preclinical testing of medicines;
- formation of registration dossier with further state registration of medicines.
The registration certificate on anti-helicobacter preparation “Vitridinol” is obtained. The preparation is aimed to treat diseases of stomach, it is researched on the basis of bismuthate tripotassium dicitrate substance of Russian production (De-Nol drug’ analogue).
The Institute cooperates hands in glove with pharmaceutical enterprises and companies: from 2005 to 2015 more than 70 scientific researches are completed in the frame of commercial agreements with enterprises and institutions of pharmaceutical type concerning research of original preparations and generics, scientific and technical documentation, technological regulations, procedures of drugs’ quality control, conducting of pre-clinical testing, preparation of documents for registration dossier, pharmaceutical examination and production’ technology transfer of medicines.
During the last decade our specialists have written 38 pharmacopoeial articles and 28 technological regulations, more than 20 new analytical methods on drugs’ QC are prepared. The results of researches were published in more than 120 scientific articles and in 12 monographs, 32 patents on inventions were obtained and 6 theses are defended.