Development and introduction innovative of drugs with neurotropic and immunotropic actions into medical practice

Work number - P 17 ALLOWED TO PARTICIPATE

Authors:

GolovenkoN.Y., VoroninaT.A., PavlovskyV.I., Karasevа T.L., NikitinE.V, YegorovaA.V., RederA.S., StelmakhI.B., PozigunD.V.

Applied by A.V.Bogatsky Physico-Chemical Institute, National Academy of Sciences of Ukraine

The fundamental chemical, pharmaceutical, biological and clinical investigations of a number of the innovative medicines with psychotropic (Phenazepam, Gidazepam, Levana) and immune stimulating (Amixin) mechanisms of effect have been carried out in accordance with the national and international standards. The medicines have been registered on the base of the complete file of documents concerning their quality, safety and efficiency (complete registration information). Development and putting the innovative medicines manufactured by the Company “INTERCHEM SLC” into wide medical practice (development of technological regulations for the synthesis of API’s, development of drugs, pre-clinical, clinical tests, registration and marketing) have been realized in accordance with Article 6 of the Law of Ukraine “About the Drugs” and the Order of the Ministry of Health of Ukraine No 426 dated 26.08.2005 which is currently in force, and Good Manufacturing Practice (GMP).

The drugs have been put into circulation under their own trade names the, rights for using of which in the production (manufacture), sale and application are protected by the legislation of Ukraine regarding the protection of the intellectual property.

Taking into consideration the practical recommendations (standards) which have been harmonized and approved on the international and national levels such drugs as Phenazepam, Gidazepam, Amixin, are included into the State Official List of Drugs.

The results of investigations are stated in 23 monographs, 12 methodological recommendations, and more than 1000 scientific reviews and articles, 47 of which were published in the English language. General number of citations of the authors publications is of 1110 (according to the Scopus database), h-index = 17. As a result of the research carried out 19 patents and 15 copyright certificates were issued. In this subject area 15doctoral theses and 46candidate’s dissertations were defended.