Creating new drugs design patterns.Step one. Pharmaceutical development

封面


如何引用文章

全文:

详细

 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., 14

Anatoliy 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., 14

Polina Andreeva

Saint-Petersburg Chemical-Pharmaceutical University, St. Petersburg

Email: polina.andreeva@pharminnotech.com

master student

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

参考

  1. Bykovskij S., Vasilenko I., Demina N. i dr. Farmacevticheskaja razrabotka. Koncepcija i prakticheskie rekomendacii. M.: Pero; 2015: 286 (In Russ.).
  2. ICH guideline Q8 (R2) on pharmaceutical development. ICH, 2017; 20.
  3. Prikaz Minpromtorga Rossii ot 14.06.2013 № 916 (red. ot 18.12.2015) «Ob utverzhdenii Pravil nadlezhashhej proizvodstvennoj praktiki» (In Russ.).
  4. Reshenie Soveta Evrazijskoj Jekonomicheskoj Komissii ot 03.11.2016 № 77 «Ob utverzhdenii Pravil nadlezhashhej proizvodstvennoj praktiki Evrazijskogo jekonomicheskogo sojuza» (In Russ.).
  5. Reshenie Soveta Evrazijskoj jekonomicheskoj komissii ot 03.11.2016 N 78 (red. ot 14.06.2018) «O Pravilah registracii i jekspertizy lekarstvennyh sredstv dlja medicinskogo primenenija» (In Russ.).
  6. Bezuglaja E.P., Ljapunov N.A. Sovremennaja metodologija farmacevticheskoj razrabotki lekarstvennyh preparatov. Farmacevticheskaja otrasl'. 2013, 36 (1) 79-86 (In Russ.).
  7. Aleksandrov A.V., Dyn'ka N.V., Zhulinskij V.A., Karpenko N.V. ICH Q8: Upravlenie riskami po kachestvu K.: Vialek, 2008; 44 (In Russ.).
  8. ICH. Quality implementation working Group on Q8, Q9 and Q10 questions & answers. ICH, 2010; 15.
  9. Lawrence X. Yu, Gregory Amidon, Mansoor A. Khan, Stephen W. Hoag, James Polli, G. K. Raju, Janet Woodcock. Understanding Pharmaceutical Quality by Design (Product Design and Understanding). The AAPS Journal. 2014, 16 (4) 771-783. doi: 10.1208/s12248-014-9598-3
  10. SchlindweinW. S., Gibson M. Pharmaceutical Quality by Design: A Practical Approach. Leicester. John Wiley & Sons: 2018: 368.
  11. GOST 19.701-90 ESKD. Shemy algoritmov, programm, dannyh i sistem. Oboznachenija uslovnye i pravila vypolnenija (In Russ.).
  12. Blok-shema algoritma. Available at: http://shkolo.ru/blok-shema-algoritma/ (accessed 02.06.2019) (In Russ.).

补充文件

附件文件
动作
1. JATS XML

版权所有 © Basevich A.V., Dzjuba A.S., Kaukhova I.E., Andreeva P.I., 2019

Creative Commons License
此作品已接受知识共享署名-非商业性使用-禁止演绎 4.0国际许可协议的许可。

СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).
Регистрационный номер и дата принятия решения о регистрации СМИ: серия ПИ № ФС 77 - 76969 от 11.10.2019. 


##common.cookie##