Abstract
Introduction. At the stage of transition from national to a uniform of circulation of pharmaceutical products regulation at the Eurasian Economic Union (EAEU) framework, harmonization of requirements for the development of medicines determines the need of use modern approaches, including the use of new methods and tools, thus to assure EAEU and other integration associations markets entry for effective and safe medicinal products. The new medicinal products development model, described in the ICH guidelines (The International Conference of Harmonization), involves a science-based approach to developing, using appropriate tools, such as defining a target product profile, establishing of critical quality indicators, risk assessment, establishment of design space, development of control strategy, drug lifecycle management and continuous improvement of existing processes. These approaches and techniques are not a part of the traditional paradigm of pharmaceutical development; although they are poorly understood and expensive, they are ensure the market entry of effective products with the desired quality parameters.Aim. Main purposes of this work are to compare two concepts of pharmaceutical developmentof medicinal products: traditional and improved, and to consider the necessity of new model usingin generic products development.Materials and methods. Research materials of this study were available literature sources, regulatory documents and guidelines regarding pharmaceutical products development, registration dossier documents, reports of regulatory authorities, pharmaceutical development reports. The achieving of study purposes was carried out on the basis of scientific research methods in the framework of comparative and logical analysis, and through the analysis and interpretation of the obtained data regarding pharmaceutical development of medicinal products.Results and discussion. On the basis of the data provided, author assess that modern concept it is a new, improved tool for development of medicinal products with specified quality parameters.Conclusion. The modern paradigm requires new expensive methods, stuff special knowledge and skills, investment and time, but it is effectively oriented on development of effective and safe medicinal products.
Highlights
At the stage of transition from national to a uniform of circulation of pharmaceutical products regulation at the Eurasian Economic Union (EAEU) framework, harmonization of requirements for the development of medicines determines the need of use modern approaches, including the use of new methods and tools, to assure EAEU and other integration associations markets entry for effective and safe medicinalРАЗРАБОТКА И РЕГИСТРАЦИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ. 2020
On the basis of the data provided, author assess that modern concept it is a new, improved tool for development of medicinal products with specified quality parameters
The modern paradigm requires new expensive methods, stuff special knowledge and skills, investment and time, but it is effectively oriented on development of effective and safe medicinal products
Summary
Метод для определения взаимо- Можно использовать для сравни- Сравнительные эксперименты используютдействия между факторами, влияющи- тельных экспериментов, отсеиваю- ся для выбора лучшей из двух альтернатив ми на процесс и результатом данного щих экспериментов, моделирования процесса поверхности отклика и регрессионного моделирования. A method for determining the It can be used for comparison ex- Comparative experiments are used to select interaction between factors that affect a periments, screening experiments, re- better of two alternatives process and the process result sponse surface modeling, and regression modeling. Критические свойст- Критические свойства веществ изуча- Физические, химические, биоло- Критические свойства в основном Неопределенная изменчивость исходных ва веществ ются на уровне, заложенном в регуля- гические или микробиологические связаны с исходными материалами материалов может сказаться на качестве торных требованиях, внутренних доку- свойства, или характеристики, кото- (действующие вещества и вспомога- конечного продукта, если определенные ментах разработчика-производителя ЛС рые должны быть в соответствующих тельные вещества), промежуточными свойства фармацевтических веществ не изупределах, диапазонах или соответст- продуктами и готовым продуктом чены в полной мере или не приняты во внивующе распределены для гарантии мание в процессе производства. Critical properties of Critical properties of substances are Physical, chemical, biological, or mic- Critical properties are mainly related The uncertain variability of raw materials can substances studied at the level laid down in the regu- robiological properties or characteristics to the raw materials (active substances affect the quality of the final product if certain latory requirements, internal documents of that must be within appropriate limits, and excipients), intermediate products, properties of pharmaceutical substances are the drug developer-manufacturer ranges, or appropriately distributed to and the finished product not fully studied or taken into account in the ensure that the required quality of the production process drug is achieved
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
