THERAPEUTIC EQUIVALENCE, BIOEQUIVALENCE AND INTERCHANGEABILITY OF MEDICINAL PRODUCTS
- Authors: Sokolov A.1, Kukes V.1, Bunatyan N.1, Rodina T.1, Prokofiev A.1, Arkhipov V.1, Krasnykh L.1, Sokova E.1
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Affiliations:
- Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
- Issue: Vol 26, No 10 (2015)
- Pages: 32-35
- Section: Articles
- URL: https://journals.eco-vector.com/0236-3054/article/view/116389
- ID: 116389
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About the authors
A. Sokolov
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
V. Kukes
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian FederationProfessor Academian of the Russian Academy os Science
N. Bunatyan
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Email: Bunyatyan@expmed.ru
T. Rodina
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
A. Prokofiev
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
V. Arkhipov
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
L. Krasnykh
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
E. Sokova
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
References
- Федеральный закон от 22.12.14 №429 «О внесении изменения в Федеральный закон «Об обращении лекарственных средств» // Министерство здравоохранения Российской Федерации [официальный сайт]. URL: http://rosminzdrav.ru/docs/mzsr/projects/1926.
- Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use / Volume 1 - Pharmaceutical Legislation Medicinal Products for Human Use // The rules governing medicinal products in the European Union (Eudralex).
- Плавинский С.Л. Являются ли препараты с одним международным непатентованным наименованием (МНН) взаимозаменяемыми? Анализ международного опыта на примере циклоспоринов // Медицина. - 2013; 4: 86-108.
- Методические рекомендации по проведению качественных клинических исследований биоэквивалентности лекарственных препаратов / М.: МЗ РФ, 2001; 24 с.
- Guideline for Good Clinical Practice E6(R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human.
- Принципы надлежащей лабораторной практики // Библиотека ГОСТов -главная [электронный ресурс].
- Davit B., Braddy A., Conner D. et al. International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences // The AAPS Journal. - 2013; 15 (4): 974-90. doi: 10.1208/s12248-013-9499-x
- Food and Drug Administration, Center for Drug Evaluation and Research. In vivo bioequivalence approaches, draft guidance. 1997. Available from URL: http://www.fda.gov/cder/guidelance/1716dft.pdf.
- Есенова И.И., Автандилов А.Г., Петросов C.Л. Оценка эффективности применения лизиноприла у молодых мужчин с артериальной гипертензией и алиментарным ожирением // Фарматека. - 2009; 4: 61-4.
- Верткин A.Л., Барабашкина А.В., Ткачева О.Н. и др. Влияние небиволола на состояние сердечно-сосудистой системы при сохраняющейся после родов артериальной гипертонии // Рос. кардиол. журн. - 2005; 2: 55-9.
- Approved Drug Products with Therapeutic Equivalence Evaluations, 33"d (2013) [Orange Book] / United States Food and Drug Administration [официальный сайт].
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