Genetic Research Application in the Study of Pharmaceuticals
https://doi.org/10.17803/2313-5395.2021.1.15.003-035
Abstract
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.
Keywords
pharmacogenetics,
biobanking,
clinical studies [clinical trials],
ethics review,
law,
legislation,
genetic material
Supporting agencies: Supported by the Russian Ministry of Science and Higher Education (Topic: Legal Regulation of Accelerated Development of Genetic Technologies: Research and Methodology Framework; No 730000Ф.99.1.БВ16АА02001).
About the Authors
A. L. Khokhlov
Yaroslavl State Medical University
Russian Federation
Russian Federation
Alexander L. Khokhlov - Corresponding Member of the Russian Academy of Sciences, Dr. Sci. (Medicine), Professor, Head of the Department of Clinical Pharmacology and Drug Use Ethics under the auspices of UNESCO, Yaroslavl State Medical University.
Revolutsionnaya St., 5, Yaroslavl, 150000.
Ph. A. Romanov
Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
Philip A. Romanov - Director of the Department for State Regulation of Circulation of Pharmaceuticals, Ministry of Health of the Russian Federation.
Sadovaya-Kundrinskaya, 9, Moscow, 125993.
A. A. Mokhov
Kutafin Moscow State Law University (MSAL)
Russian Federation
Russian Federation
Alexander A. Mokhov - Dr. Sci. (Law), Professor, Head of the Department of Medical Law, Kutafin Moscow State Law University (MSAL).
Sadovaya-Kudrinskaya St., 9, Moscow, 125993.
N. O. Pozdnyakov
Yaroslavl State Medical University
Russian Federation
Russian Federation
Nikolay O. Pozdnyakov - Cand. Sci. (Medicine), Researcher, Department of Clinical Pharmacology and Drug Use Ethics under the auspices of UNESCO, Yaroslavl State Medical University.
Revolutsionnaya St., 5, Yaroslavl, 150000.
A. E. Miroshnikov
Yaroslavl State Medical University
Russian Federation
Russian Federation
Alexey E. Miroshnikov - Cand. Sci. (Medicine), Researcher, Department of Clinical Pharmacology and Drug Use Ethics under the auspices of UNESCO, Yaroslavl State Medical University.
Revolutsionnaya St., 5, Yaroslavl, 150000.
A. N. Yavorsky
Pushchino State Institute of Natural Science
Russian Federation
Russian Federation
Alexander N. Yavorsky - Dr. Sci. (Medicine), Professor, Chief Researcher, Pushchino State Institute of Natural Science.
Nauki Av., 3, Pushchino, Moscow Region, 142290.
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For citations:
Khokhlov A.L., Romanov P.A., Mokhov A.A., Pozdnyakov N.O., Miroshnikov A.E., Yavorsky A.N. Genetic Research Application in the Study of Pharmaceuticals. Kutafin Law Review. 2021;8(1):3-35. https://doi.org/10.17803/2313-5395.2021.1.15.003-035
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