Creating new drugs design patterns.Step one. Pharmaceutical development

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Abstract

 To optimize the process of pharmaceutical development, it is necessary to take into account the timeframes of the processes and to track all its key stages. To do this, it is necessary to create an algorithm for conducting research, taking into account the modern approach to pharmaceutical development — the concept of Quality by Design.

The aim of this work was to create an algorithm of actions in conducting research when developing a new drug that can be used in the production process.

Flowcharts were used for depicting algorithms. To account the timeframes of the processes, a Gantt diagram was used.

The process of pharmaceutical development when launching a new generic drug has been studied at an operating pharmaceutical company. An algorithm for the actions of staff involved in research is proposed The algorithm minds the concept of Quality by Design. A temporary Gannta scheme and a project manager's control card for the process of pharmaceutical development of a generic drug have been developed.

Based on the results of the work, an algorithm of actions in conducting research when developing a new drug that can be used in the production process was proposed.

About the authors

Anna V. Basevich

Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg

Author for correspondence.
Email: anna.basevich@pharminnotech.com
SPIN-code: 8189-3806
Scopus Author ID: 689173

PhD of Pharmaceutical Sciences, Associate Professor at the Industrial technology of medicines Department

Russian Federation, 197376, St. Petersburg, Professora Popova st., 14

Anatoliy S. Dzjuba

Pharmproject JSC, St. Petersburg

Email: anatoly.dzuba@pharminnotech.com

PhD of Pharmaceutical Sciences, Head of development Department, JSC «Farmproekt»

Russian Federation

Irina E. Kaukhova

Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg

Email: irina.kaukhova@pharminnotech.com
SPIN-code: 2931-5790
Scopus Author ID: 736701

Doctor of Pharmaceutical Sciences, Professor, Head of the Industrial technology of medicines Department,

Russian Federation, 197376, St. Petersburg, Professora Popova st., 14

Polina I. Andreeva

Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg

Email: polina.andreeva@pharminnotech.com

master student

197376, St. Petersburg, Professora Popova st., 14

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Copyright (c) 2019 Basevich A.V., Dzjuba A.S., Kaukhova I.E., Andreeva P.I.

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