Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia Federation

In Russia the evaluation of bioequivalence of drugs for more than ten years the main requirement of medical and biological control of generic drugs. Regardless of manufacturer to the generic drugs are exactly the same as the original drug, must meet the following requirements: quality, efficiency an...

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Main Authors: A. L. Khokhlov, E. G. Lileeva
Format: Article
Language:Russian
Published: Izdatelstvo OKI 2018-05-01
Series:Качественная клиническая практика
Subjects:
Online Access:https://www.clinvest.ru/jour/article/view/49
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author A. L. Khokhlov
E. G. Lileeva
author_facet A. L. Khokhlov
E. G. Lileeva
author_sort A. L. Khokhlov
collection DOAJ
description In Russia the evaluation of bioequivalence of drugs for more than ten years the main requirement of medical and biological control of generic drugs. Regardless of manufacturer to the generic drugs are exactly the same as the original drug, must meet the following requirements: quality, efficiency and safety. In connection with the increase in recent years of bioequivalence studies of medicinal products requires careful control over the quality of these studies on the territory of the Russian Federation.
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spelling doaj.art-a54b90aeb53340f997d53d0f3c14222b2024-03-14T18:09:03ZrusIzdatelstvo OKIКачественная клиническая практика2588-05192618-84732018-05-0102647049Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia FederationA. L. Khokhlov0E. G. Lileeva1ФГБОУ ВО Ярославский государственный медицинский университет МЗ РФФГБОУ ВО Ярославский государственный медицинский университет МЗ РФIn Russia the evaluation of bioequivalence of drugs for more than ten years the main requirement of medical and biological control of generic drugs. Regardless of manufacturer to the generic drugs are exactly the same as the original drug, must meet the following requirements: quality, efficiency and safety. In connection with the increase in recent years of bioequivalence studies of medicinal products requires careful control over the quality of these studies on the territory of the Russian Federation.https://www.clinvest.ru/jour/article/view/49исследования биоэквивалентностиисследования фармакокинетикикачество проведения исследованийфармакогенетическое тестированиеbioequivalence studiespharmacokinetic studiesquality of researchpharmacogenetic testing
spellingShingle A. L. Khokhlov
E. G. Lileeva
Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia Federation
Качественная клиническая практика
исследования биоэквивалентности
исследования фармакокинетики
качество проведения исследований
фармакогенетическое тестирование
bioequivalence studies
pharmacokinetic studies
quality of research
pharmacogenetic testing
title Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia Federation
title_full Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia Federation
title_fullStr Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia Federation
title_full_unstemmed Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia Federation
title_short Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia Federation
title_sort analysis of the quality of bioequivalence and pharmacokinetics studies in russia federation
topic исследования биоэквивалентности
исследования фармакокинетики
качество проведения исследований
фармакогенетическое тестирование
bioequivalence studies
pharmacokinetic studies
quality of research
pharmacogenetic testing
url https://www.clinvest.ru/jour/article/view/49
work_keys_str_mv AT alkhokhlov analysisofthequalityofbioequivalenceandpharmacokineticsstudiesinrussiafederation
AT eglileeva analysisofthequalityofbioequivalenceandpharmacokineticsstudiesinrussiafederation