Creating new drugs design patterns.Step one. Pharmaceutical development

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.


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

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

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

Anatoliy S. Dzjuba

Pharmproject JSC, St. Petersburg

Email: anatoly.dzuba@pharminnotech.com

Russian Federation

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

Irina E. Kaukhova

Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg

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

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

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

Polina I. Andreeva

Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg

Email: polina.andreeva@pharminnotech.com
197376, St. Petersburg, Professora Popova st., 14

master student

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