Genetic Research Application in the Study of Pharmaceuticals
| العنوان: | Genetic Research Application in the Study of Pharmaceuticals |
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| المؤلفون: | A. A. Mokhov, N. O. Pozdnyakov, A. L. Khokhlov, A. N. Yavorsky, A. E. Miroshnikov, Ph. A. Romanov |
| المصدر: | Kutafin Law Review. 8:3-35 |
| بيانات النشر: | Kutafin Moscow State Law University, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | 0301 basic medicine, business.industry, Legislation, Harmonization, 030204 cardiovascular system & hematology, Biobank, Biological materials, Clinical trial, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Risk analysis (engineering), Personalized medicine, business, Pharmacogenetics, Pharmaceutical industry |
| الوصف: | The current science and research trends, as well as the development of personalized medicine, point to the need to use genetic tests in course of the study of pharmaceuticals. Pharmacogenetic testing has become indispensable when developing new pharmaceuticals in order to study both the peculiarities of pharmacodynamic effects or the prospects of personalized treatment, and the characteristics of metabolism or drug-drug interaction. In addition, the introduction of pharmacogenetics in bioequivalence studies allows limiting, at early stages, the criteria for inclusion or non-inclusion of volunteers based on certain gene polymorphisms determining the metabolic rate.The study of the genetic characteristics of clinical trial participants allows a more detailed analysis of the role of gene polymorphisms in terms of both pharmacokinetics and pharmacodynamics of the studied pharmaceuticals.A separate important issue is genetic material collection from the clinical trial participants. On the one hand, the use of biological material collections is an essential tool for accomplishing the practical tasks in both the pharmaceutical industry and the state-of-the-art medicine. On the other hand, the legal review and ethics review of genetic material collection and use can become formidable barriers to the development of biobanking. The existing legislative differences between Russia and other countries allow identifying the most challenging regulatory aspects, and can contribute to international law harmonization in the sphere of biobanking in the future. |
| تدمد: | 2410-2059 2313-5395 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::3b17684e6f5a13369c958a2067c0cd3c https://doi.org/10.17803/2313-5395.2021.1.15.003-035 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi...........3b17684e6f5a13369c958a2067c0cd3c |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 24102059 23135395 |
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