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Подтверждение терапевтической эквивалентности – первый шаг к взаимозаменяемости лекарственных препаратов
Миронов А.Н., Васильев А.Н., Гавришина Е.В., Ниязов Р.Р., Ромодановский Д.П., Горячев Д.В. Подтверждение терапевтической эквивалентности – первый шаг к взаимозаменяемости лекарственных препаратов. Consilium Medicum. 2014; 16 (2): 78–84.
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Список литературы
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24. Государственный реестр лекарственных средств Российской Федерации. http://grls.rosminzdrav.ru/
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28. Biologics Price Competition and Innovation Act of 2009. United States Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf
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31. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (Draft Guidance). Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
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37. Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005). European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf
38. New Labelling Information for all Botulinum Toxin Products: Botox/Botox Cosmetic, Dysport, Xeomin/Xeomin Cosmetic and Myobloc. Health Canada. http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_07-eng.php
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40. Проект Федерального закона от 3 сентября 2013 г. «О внесении изменения в Федеральный закон «Об обращении лекарственных средств» и в статью 333.32.1 части второй Налогового кодекса Российской Федерации». Министерство здравоохранения Российской Федерации. https://www.rosminzdrav.ru/docs/doc_projects/956
2. Давыдова К.С. Оценка эквивалентности воспроизведенных лекарственных средств. Фармация. 2011; 3: 51–4.
3. Давыдова К.С., Шохин И.Е., Раменская Г.В., Кукес В.Г. Подходы к оценке эквивалентности воспроизведенных лекарственных средств в современной фармацевтической практике. Вiсник фармацii. 2010; 3: 66–8.
4. Миронов А.Н., Васильев А.Н., Гавришина Е.В. и др. Взаимозаменяемость лекарственных препаратов: зарубежный опыт, препятствия и условия становления концепции в России, роль научной экспертизы. Ремедиум. 2013; 10: 8–17.
5. Truus Janse-de Hoog, European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/06/WC500107873
6. Approved Drug Products with Therapeutic Equivalence Evaluations, 33nd (2013) [Orange Book]. United States Food and Drug Administration. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf.
7. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolidated version: 20/01/2011). OJ L 311, 28.11.2001, p. 67.
8. Utbytbara läkemedel. Läkemedelsverket (Medical Products Agency). http://www.lakemedelsverket.se/upload/halso-och-sjukvard/forskrivning/utbytbarhet/gk_utbytbara%20gru...
9. Gustafsson LL. Der Hauptverband der österreichischen Sozialversicherungsträger. http://www.hauptverband.at/mediaDB/777660_Generics_in_Sweden.pdf
10. Взаимозаменяемость лекарственных препаратов в ФРГ. PharmActa: Quality and Standards, Москва, 2013 [электронный ресурс].
11. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 7). World Health Organization. WHO Technical Report Series, No. 937, 2006. http://apps.who.int/prequal/info_general/documents/TRS937/WHO_TRS_937__annex7_eng.pdf
12. Federal Food, Drug, and Cosmetic Act, Sec. 355 New Drugs, (j) Abbreviated new drug applications. United States Food and Drug Administration. http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec35....
13. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (08/01/00). United States Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070246.pdf
14. Federal Food, Drug, and Cosmetic Act, Part 320 – Bioavailability and Bioequivalence Requirements, Subpart A–General Provisions, Sec. 320.1 Definitions(e). United States Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.1
15. Investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf
16. Денисова Т.А., Садчикова Н.П. Пробл. репродукции. 2010; 3: 117–24.
17. Методические указания «Проведение качественных исследований биоэквивалентности лекарственных средств» (утв. Министерством здравоохранения и социального развития Российской Федерации от 30 августа 2004 г.).
18. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations (03/01/03). United States Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf
19. Dissolution Testing of Immediate Release Solid Oral Dosage Forms (08/01/97). United States Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070237.pdf
20. Draft Guidance on Acarbose. United States Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM170242.pdf.
21. Title 21 Code of Federal Regulations, Sec. 314.126 Adequate and well-controlled studies. United States Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.126
22. Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. United States Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078749.pdf
23. Presentation and content of the dossier: Common Technical Document (CTD). The rules governing medicinal products in the European Union (Eudralex). http://ec.europa.eu/health/files/eudralex/vol-2/b/update_200805/ctd_05-2008_en.pdf
24. Государственный реестр лекарственных средств Российской Федерации. http://grls.rosminzdrav.ru/
25. Федеральный закон от 12 апреля 2010 г. № 61-ФЗ «Об обращении лекарственных средств» [Принят Гос. Думой 24 марта 2010 г. с изменениями и дополнениями по состоянию на 6 декабря 2011 г.]. Российская газета – Федеральный выпуск № 5157 от 12 апреля 2010 г.
26. Volume 4 Good manufacturing practice (GMP) Guidelines. The rules governing medicinal products in the European Union (Eudralex). http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
27. Kurt R. Karst, FDA: Law Blog. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/01/biosimilar-substitution-battles-are-brew...
28. Biologics Price Competition and Innovation Act of 2009. United States Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf
29. Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 (Draft Guidance Updated for 508 on 3/22/12). Food and Drug Administration. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm259797.htm
30. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Draft Guidance). Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
31. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (Draft Guidance). Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
32. Shapiro M, United States Food and Drug Administration. http://www.fda.gov/90A3D233-A7F1-4C67-A0F7-3C539C102417/FinalDownload/DownloadId-5269EEA4335F5B267F8...
33. Mattaliano RJ. United States Food and Drug Administration. http://www.fda.gov/90A3D233-A7F1-4C67-A0F7-3C539C102417/FinalDownload/DownloadId-5269EEA4335F5B267F8...
34. McCamish M. United States Food and Drug Administration. http://www.fda.gov/90A3D233-A7F1-4C67-A0F7-3C539C102417/FinalDownload/DownloadId-5269EEA4335F5B267F8...
35. Similar biological medicinal products (CHMP/437/04). European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf
36. Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (EMEA/CHMP/BWP/49348/2005). European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf
37. Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005). European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf
38. New Labelling Information for all Botulinum Toxin Products: Botox/Botox Cosmetic, Dysport, Xeomin/Xeomin Cosmetic and Myobloc. Health Canada. http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_07-eng.php
39. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs) (WHO/BS/09.2110). World Health Organization. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
40. Проект Федерального закона от 3 сентября 2013 г. «О внесении изменения в Федеральный закон «Об обращении лекарственных средств» и в статью 333.32.1 части второй Налогового кодекса Российской Федерации». Министерство здравоохранения Российской Федерации. https://www.rosminzdrav.ru/docs/doc_projects/956
Авторы
А.Н.Миронов, А.Н.Васильев, Е.В.Гавришина, Р.Р.Ниязов, Д.П.Ромодановский, Д.В.Горячев
ФГБУ Научный центр экспертизы средств медицинского применения Минздрава России, Москва
ФГБУ Научный центр экспертизы средств медицинского применения Минздрава России, Москва
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