The theoretical fundamentals and methodical substantiation of the complex analysis and modeling of expediency and efficiency when developing new medicines
Keywords:new medicines, attractiveness, expediency, efficiency, capability, projects, risks, scientific research, investments, innovations
Aim. To summarize theoretically and substantiate scientifically and methodically the methodological approach to the complex analysis of practical stages of the organizational and technological process of research works in order to predict the social necessity, medical expediency, economic efficiency, commercial capability and investment attractiveness for developing new medicines and making an appropriate investment decision.
Materials and methods. As materials the scientific publications, reports and completed research works regarding development of medicines, individual studies and results of monitoring of the drug retail market of the “Pharmstandard” company were used. The methods of generalization, systematization of theoretical and practical material, marketing analysis, graphic, comparative, and economic methods, as well as modeling were applied.
Results. The materials concerning the methodological substantiation of stages and works in the process of developing new medicines of new generations have been studied, and their logical consequence and interrelations have been determined. The flowchart of “a road map” modules determining expediency, efficiency and investment attractiveness for developing and using a new medicine has been worked out. The components of each module and initial data, and their use in further stages of the project implementation as a product have been determined. The complex program of the predictive estimate of projects by the scenarios of the event development has been elaborated; its basic indicators are marketing, medical, pharmaceutical, economic and financial indicators.Conclusions. The possibility of a complex estimation of the organizational and technological process of projects in development and use of generic medicines of new generations based on modeling of comprising stages of work in order to make a rational investment and management decision using indicators of efficiency, expediency, attractiveness and capability of the project has been substantiated.
Baigush, Yu. V, Samborskyi, O. S, Slobodianiuk, M. M. (2016). Proceedings of Upravlinnia yakistiu v farmatsii: zbirnyk naukovykh robit X naukovo-praktychoi konferentsii z mizhnarodnoiu uchastiu (20 travnia 2016). (pp. 18–20). Kharkiv: NFaU.
Dorovskoi, A. V. (2014). Problemy ekonomiky, (3), 71–80.
Dremova, N. B., Korzhavykh, E. A. (2006). Novaya apteka, (8), 70–79.
Sobolieva, T. O. (2008). Upravlinnia formuvanniam ta realizatsiieiu innovatsiinoho potentsialu pidpryiemstva (za materialamy farmatsevtychnykh pidpryiemstv Ukrainy). Extended abstract of candidate’s thesis. Kyiv, 20.
Lipkova, L., Braga D. (2016). Measuring Commercialization Success Of Innovations In The Eu. Marketyng i menedzhment innovacii, (4), 15–30.
Slobodianiuk, M. M, Samborskyi, O. S. (2017). Proceedings of Socialna farmaciia: stan, problemy ta perspektyvy: materialy III mizhnarodnoi naukovo-praktychoi internet-konferentsii (25-28 kvitnia 2017). (pp. 180–183). Kharkiv: NFaU.
Slobodianiuk, M. M, Samborskyi, O. S. (2016). Proceedings of Suchasni dosiahnennia farmatsevtychnoi tekhnolohii ta biotekhnolohii: materialy V naukovo-praktychoi internet-konferentsii z mizhnarodnoiu. uchastiu (18.11.2016). (pp. 557–560). Kharkiv: NFaU.
Samborskyi, O., Slobodianiuk, M., Yevtushenko, O. (2017). There is a question of risk and management of vagueness processes in the field of pharmacy. The scientific heritage. (Budapest, Hungary), 9 (9), 26–35.
Samborskyi, O., Slobodianiuk, M., Baigush, Yu, (2017). A foundation of scientific and practical approaches to determination of expediency and investment attractiveness of the new antihypertensive medicines development. The scientific heritage. (Budapest, Hungary), 14 (14 (1)), 36–42.
Mensh, G. (1979). Stalemate in technology: Innovation Overcome the Depression.Cambridge : Mass, 241.
Scannell, J., Blanckley, A., Boldon, H., Warrington, B. (2012). Diagnosing the decline in pharmaceutical R&D efficiency. Nature Reviews. Drug Discovery, (11), 191–200.
Pashkov, V. (2013). Visnyk Natsionalnoi akademii pravovykh nauk Ukrainy,3 (74), 204–213.
Posylkina, O. V. (2004). Visnyk farmatsii, 3 (39), 59–62.
DiMasi, J. A., Hansen, R. W., Grabowski, H. G., Lasagna, L. (1991). Cost of innovation in the pharmaceutical industry. Journal of Health Economics,10 (2), 107–142.
Xonl, T. A. (2013). Problemy ucheta i finansov, 2 (10), 52–54.
Barratt, M. J., Frail, D. E. (Eds.). (2012). Drug repositioning: bringing new life to shelved assets and existing drugs. New Jercey: Willey, 470. doi: 10.1002/9781118274408.
Demkin, Y. V., Streltsov, A. V., Galetov, Y. D. (2004). Upravlenie riskom, (4), 16–27.
Kovalenko, Sv. M. (2015). Visnyk farmatsii, (4) 84, 47–51.
Usherenko, S. V., Chernenko, D. D. (2015). Chasopys ekonomichnykh reform, 2 (18), 92–98.
Sokolova, E. (2013). Innovatsii dostupnye kazhdomu. ZN,ua. Retrieved from: http://gazeta.zn.ua/HEALTH/innovacii-dostupnye-kazhdomu-_.html/.
Samborskyi, O. S., Slobodianiuk, M. M. (2015). Proceedings of Tekhnolohichni ta biofarmatsevtychni aspekty stvorennia likarskykh preparativ riznoi napravlenosti dii: materialy II mizhnarodnoi naukovo-praktychoi internet-konferentsii (12-13.11.2015). (pp. 215–216). Kharkiv: NFaU.
Federalne upravlinnia SShA po kontroliu za kharchovymy produktamy ta likarskymy zasobamy. Retrieved from: http://www.fda.gov/.
Davydova, T. V. (2013). Visnyk NTU «KhPI», 50 (1023), 24–29.
Lesyk, R. (2006). Farmatsevt Praktyk, (7-8), 25–27.
Nakaz Ministerstva ohorony zdorovia Ukrayiny No 97 vid 20.08.2010 DP “Derzhavnyi farmakolohichnyi tsentr” “Pro zatverdzhennia roztsinok vartosti posluh, shcho nadaiutsia DP “Derzhavnyi farmakolohichnyi tsentr” MOZ Ukrainy”. Retrieved from: http://document.ua/pro-zatverdzhennja-rozcinok-vartosti-poslug-sho-nadayutsja-d-doc31883.html.
Slobodianiuk, M. M, Samborskyi, O. S. (2017). Proceedings of Aktualni problemy rozvytku haluzevoi ekonomiky ta lohistyky: materialy V mizhnarodnoi naukovo-praktychoi konferentsii (20-21 kvitnia 2017). (pp. 291–294). Kharkiv: NFaU.
Innovatsionnoe upravlenie. Klassifikatsiia innovatsii. Retrieved from: http://innovation-management.ru/vidy-innovaczij.
Klunko, N. S. (2013). Visnyk NTU «KhPI», 21 (994), 97–104.
Klunko, N. S. (2012). BIZNES INFORM, (5), 72–75.
Klunko, N. S. (2012). BIZNES INFORM, (2), 61–66.
Posylkina, O. V. (2002). Innovatsiino-investytsiinyi rozvytok farmatsevtychnoho vyrobnytstva: problemy finansovoho zabezpechennia. Kharkiv: NFAU: Zoloti storinky, 528.
Ding, M., Eliashberg, J., Stremersch, St.(2014). Marketing in the Pharmaceutical Industry. Editors Emerging Practices, Research, and Policies. Chapter 3. Portfolio Management in New Drug Development.New York, 83–117.
DiMasi, J. A., Hansen, R. W., Grabowski, H. G. (2003). The price of innovation: new estimates of drug development costs. Journal of Health Economics, 22 (3), 141–185. doi: 10.1016/s0167-6296(02)00126-1.
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