Creating new drugs design patterns.Step one. Pharmaceutical development
Anna V. Basevich , Anatoliy S. Dzjuba , Irina E. Kaukhova , Polina I. Andreeva
Pharmacy Formulas ›› 2019, Vol. 1 ›› Issue (1) : 22 -31.
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.
Pharmaceutical development, generic, algorithm, quality by design
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Basevich A.V., Dzjuba A.S., Kaukhova I.E., Andreeva P.I.
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