publication . Article . 2019

Approaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislation

Dobrovolskiy, A. V.;
Open Access Russian
  • Published: 25 Mar 2019 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 9, issue 1, pages 14-27 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
Abstract
In recent years, there has been an increasing interest in the development of combination medicines (fixed drug combinations) containing two or more active ingredients in a single dosage form. Therefore, there is an urgent need to develop an optimal programme of pre-authorisation clinical trials for combination medicines. The aim of the paper was to summarise modern science-based approaches to clinical development of combination medicines and identify possible ways of their practical implementation, taking into account the requirements of the current legislation. The author reviewed scientific publications devoted to creation of fixed drug combinations and analys...
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free text keywords: combination medicines, fixed drug combination, clinical development, clinical trial, authorisation of medicines, regulatory requirements, Medicine (General), R5-920, Authorization, Legislation, Accounting, business.industry, business, Economic union, Russian federation, Clinical trial
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