SYSTEM APPROACH TO INFORMATIONAL SUPPORT OF PHARMACEUTICAL DEVELOPMENT OF FINISHED MEDICINAL PRODUCTS
https://doi.org/10.32362/2410-6593-2018-13-2-91-99
Abstract
The article considers the application of the system approach for constructing informational support for the life cycle of the production of medicinal products. The principal difficulties of creating a single informational system of the entire life cycle are considered in this article. A brief analysis of the information and computer support of individual links in the life cycle is given. Particular attention is paid to the use of a systematic approach to the creation of information support for the pharmaceutical development of medicines. The principle of QbD - “Quality planned for development” - was taken as a basis. For the implementation the QbD principle on the basis of the system approach, it is proposed to use the Shewhart-Deming iteration cycle to create an information support for a sustainable search for the optimal version (the program) of the conducted studies. The possibility of combining the PDCA cycle and the methodology of the system approach is shown. On its basis, system-theoretic multiple models of nformation support for pharmaceutical development in the graphic-analytical nomination were constructed. The method of applying the criterial approach for the formation of global and local criteria for managing research and the construction of system management models in the Melentiev’s brackets nomination are presented. The information modeling of the stage of pharmaceutical development has been carried out. Functional models have been constructed in the IDEF0 nomination.
About the Authors
V. F. Kornushko
Moscow Technological University (M.V. Lomonosov Institute of Fine Chemical Technologies)
Russian Federation
Russian Federation
Dr.Sc. (Engineering), Professor of the Chair of Information Systems in Chemical Technology
86, Vernadskogo Pr., Moscow 119571, Russia
A. V. Panov
Moscow Technological University (M.V. Lomonosov Institute of Fine Chemical Technologies)
Russian Federation
Russian Federation
Ph.D. (Chemistry), Associate Professor of the Chair of Biotechnology and Industrial Pharmacy
86, Vernadskogo Pr., Moscow 119571, Russia
I. V. Bogunova
Moscow Technological University (M.V. Lomonosov Institute of Fine Chemical Technologies)
Russian Federation
Russian Federation
Senior Lecturer of the Chair of Biotechnology and Industrial Pharmacy
86, Vernadskogo Pr., Moscow 119571, Russia
O. M. Nikolayeva
Moscow Technological University (M.V. Lomonosov Institute of Fine Chemical Technologies)
Russian Federation
Russian Federation
Postgraduate Student of the Chair of Information Systems in Chemical Technology
86, Vernadskogo Pr., Moscow 119571, Russia
A. A. Flid
Moscow Technological University (M.V. Lomonosov Institute of Fine Chemical Technologies)
Russian Federation
Russian Federation
Postgraduate Student of the Chair of Information Systems in Chemical Technology
86, Vernadskogo Pr., Moscow 119571, Russia
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Review
For citations:
Kornushko V.F., Panov A.V., Bogunova I.V., Nikolayeva O.M., Flid A.A. SYSTEM APPROACH TO INFORMATIONAL SUPPORT OF PHARMACEUTICAL DEVELOPMENT OF FINISHED MEDICINAL PRODUCTS. Fine Chemical Technologies. 2018;13(2):91-99. (In Russ.) https://doi.org/10.32362/2410-6593-2018-13-2-91-99
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