Abstract
The development of new medicines is one of the priority areas of translational medicine. A significant role for biomarkers (BM) that assess the safety and efficacy of new drugs. The right choice of BM reduces the time and costs necessary for the development of drugs and transfer them to the clinic. The review is devoted to the analysis of modern scientific literature on the role of previously known and newly discovered BM in translational research. Translational BM (TBM) established during preclinical studies and are applicable at all stages of the study. TBM should have a high sensitivity and specificity, be easily measured in real time in an easily accessible biological fluids, to evaluate the same process in different species of animals (including humans), make it possible to compare the results of clinical trials with preclinical. The main role of the TBM toxicity to predict, identify and monitor the toxicity of drugs at all stages of their study. The international consortium (Predictive Safety Testing Consortium, PSTC) whose main task is the qualification of new TBM toxicity and the search for new, more advanced than existing methods for testing markers, was established. Under PSTC formed 6 working groups, each of which coordinates research for the study and selection of TBM toxicity caused by the administration of drugs in the liver, kidney, heart and blood vessels, skeletal muscle, testes. The first qualified consortium markers were 7 contained in the urine markers for preclinical studies on rats with the goal of establishing early lesions in the kidney induced by drugs. Only a small number of BM used in the study of new drugs, can be translational.
Highlights
The international consortium (Predictive Safety Testing Consortium, Predictive Safety Testing Con sortium (PSTC)) whose main task is the qualification of new Translational BM (TBM) toxicity and the search for new, more advanced than existing methods for testing markers, was established
Under PSTC formed 6 working groups, each of which coordinates research for the study and selection of TBM toxicity caused by the administration of drugs in the liver, kidney, heart and blood vessels, skeletal muscle, testes
The first qualified consortium markers were 7 contained in the urine markers for preclinical studies on rats with the goal of establishing early lesions in the kidney induced by drugs
Summary
Разработка новых лекарственных средств является одним из приоритетных направлений трансляционной медицины. Существенная роль отводится биомаркерам (БМ), оценивающим безопасность и эффективность новых препаратов. Трансляционные БМ (ТБМ) устанавливаются во время доклинических испытаний и применяются на всех этапах исследования. Основная роль ТБМ токсичности – предсказывать, определять и отслеживать токсичность препаратов на всех этапах их изучения. Создан международный консорциум (Predictive Safety Testing Consortium, PSTC), основной задачей которого является квалификация новых ТБМ токсичности и поиск новых, более совершенных, чем существующие, методов тестирования маркеров. В рамках PSTC сформировано 6 рабочих групп, каждая из которых координирует исследования по изучению и отбору ТБМ токсичности, вызванной введением препаратов, в печени, почках, сердце и сосудах, скелетной мускулатуре, семенниках. Первыми квалифицированными консорциумом маркерами были 7 содержащихся в моче маркеров для доклинических исследований на крысах с целью установления ранних поражений в почках, индуцированных действием препаратов.
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