电邮这篇文章 Creating new drugs design patterns.Step one. Pharmaceutical development
- 作者: Basevich A.V.1, Dzjuba A.S.2, Kaukhova I.E.1, Andreeva P.I.1
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隶属关系:
- Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg
- Pharmproject JSC, St. Petersburg
- 期: 卷 1, 编号 1 (2019)
- 页面: 22-31
- 栏目: Pharmaceutical Sciences
- URL: https://journals.eco-vector.com/PharmForm/article/view/18519
- DOI: https://doi.org/10.17816/phf18519
- ID: 18519
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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.
作者简介
Anna Basevich
Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg
编辑信件的主要联系方式.
Email: anna.basevich@pharminnotech.com
SPIN 代码: 8189-3806
Scopus 作者 ID: 689173
PhD of Pharmaceutical Sciences, Associate Professor at the Industrial technology of medicines Department
俄罗斯联邦, 197376, St. Petersburg, Professora Popova st., 14Anatoliy Dzjuba
Pharmproject JSC, St. Petersburg
Email: anatoly.dzuba@pharminnotech.com
PhD of Pharmaceutical Sciences, Head of development Department, JSC «Farmproekt»
俄罗斯联邦Irina Kaukhova
Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg
Email: irina.kaukhova@pharminnotech.com
SPIN 代码: 2931-5790
Scopus 作者 ID: 736701
Doctor of Pharmaceutical Sciences, Professor, Head of the Industrial technology of medicines Department,
俄罗斯联邦, 197376, St. Petersburg, Professora Popova st., 14Polina Andreeva
Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg
Email: polina.andreeva@pharminnotech.com
master student
197376, St. Petersburg, Professora Popova st., 14参考
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