Диссертация (1141356), страница 30
Текст из файла (страница 30)
Canada approves stem cell product/ D. Cyranoski // Nature Biotechnology. – 2012.– 30(7). – P. 571.82.DerivationandCharacterisationofCellSubstratesUsedforProductionofBiotechnological/Biological Products, CPMP/ICH/294/95. ICH Q5D // International Council forHarmonisation of Technical Requirements for Pharmaceuticals for Human Use [Электронныйресурс].–1998.-Режимдоступа:http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5D/Step4/Q5D_Guideline.pdf, свободный. – Загл. с экрана.83.Detailed guidelines on good clinical practice specific to advanced therapy medicinal products//EuropeanCommission[Электронныйресурс].–2009.-Режимдоступа:http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-10/2009_11_03_guideline.pdf,свободный. – Загл.
с экрана.84.Dolgin, E. Next-generation stem cell therapy poised to enter EU market/ E. Dolgin //Naturebiotechnology. – 2015. – 33(3). – P. 224-225.85.European Pharmacopoeia 8.0, vol. 1. Council of Europe, Strasbourg, 2014. — 1380 p.86.Fishman, J. A. Transmission of infection with human allografts: essential considerations in donorscreening/ J. A. Fishman, M. A. Greenwald, P. A. Grossi //Clinical infectious diseases.
– 2012. –55(5). – P. 720-727.87.Food and Drug regulations // Government of Canada [Электронный ресурс]. - 2013. - Режимдоступа: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/index.html, свободный. –Загл. с экрана.88.Gálvez, P. Development of a cell-based medicinal product: regulatory structures in the EuropeanUnion/ P. Gálvez, B. Clares, A. Hmadcha et al. //British medical bulletin. – 2013. – 105(1). – P.85-105.89.George, B. Regulations and guidelines governing stem cell based products: clinical considerations/B. George //Perspectives in clinical research. – 2011.
– 2(3). – P. 94-99.90.Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development,Manufacturing, and Quality Assurance // Food and Drug Administration [Электронный ресурс],2004. - Режим доступа: http://www.fda.gov/downloads/drugs/guidances/ucm070305.pdf,свободный. – Загл. с экрана.13991.Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellularand Gene Therapy Products // US Food and Drug Administration [Электронный ресурс]. – 2015.-Режимдоступа:http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM359073.pdf, свободный. – Загл. с экрана.92.Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements forManufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) // USFood and Drug Administration [Электронный ресурс].
– 2011. - Режим доступа:http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM285223.pdf, свободный. – Загл. с экрана.93.Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellularand Tissue-Based Products (HCT/Ps) // US Food and Drug Administration [Электронныйресурс].–2007.-Режимдоступа:http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm091345.pdf, свободный. – Загл.
с экрана.94.Guidance for Industry: Investigating and Reporting Adverse Reactions Related to Human Cells,Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 ofthe Public Health Service Act and 21 CFR Part 1271 // US Food and Drug Administration[Электронныйресурс].–2015.-Режимдоступа:http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM434834.pdf, свободный.
– Загл. с экрана.95.Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene TherapyProducts // US Food and Drug Administration [Электронный ресурс]. – 2013. - Режим доступа:http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm376136.htm, свободный. – Загл. с экрана.96.Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current GoodManufacturing Practice // US Food and Drug Administration [Электронный ресурс].
– 2004. Режим доступа: http://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf, свободный.– Загл. с экрана.97.Guide to good manufacturing practice for medicinal products. Part I, Annex 2. Manufacture ofbiological medicinal substances and products for human use // Pharmaceutical InspectionConvention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) [Электронныйресурс]. – 2014.
- Режим доступа: http:// www.fda.gov.ph/attachments/article/224762/pe-00911-gmp-guide-xannexes.pdf, свободный. – Загл. с экрана.14098.Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment //Human Tissue Authority, UK [Электронный ресурс]. - 2010. - Режим доступа:https://www.hta.gov.uk/sites/default/files/Annex__Guide_to_Quality_and_Safety_Assurance_for_Tissues_and_Cells_for_Patient_Treatment.pdf,свободный.
– Загл. с экрана.99.Guide to the quality and safety of tissues and cells for human application //European Directoratefor the Quality of Medicine & HealthCare, Council of Europe [Электронный ресурс]. - 2015. Режимдоступа:https://www.edqm.eu/sites/default/files/foreword_list_of_contents_tissues_cell_guide_2nd_edition_2015.pdf , свободный. – Загл. с экрана.100. Guideline on human cell-based medicinal products // EMEA, Committee for Human MedicinalProducts[Электронныйресурс].–2008.-Режимдоступа:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003894.pdf, свободный.
– Загл. с экрана.101. Guideline on potency testing of cell-based immunotherapy medicinal products for the treatmentof cancer// EMEA, Committee for Human Medicinal Products [Электронный ресурс]. - 2008. Режимдоступа:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003814.pdf, свободный.
– Загл. с экрана.102. Guideline on risk management systems for medicinal products for human use// EMEA, Committeefor Human Medicinal Products [Электронный ресурс]. – 2005. - Режим доступа:http://www.emwa.org/Documents/Freelancer/riskmanagement/rmp%20guidelines.pdf,свободный. – Загл. с экрана.103. Guidelines for good manufacturing practice for medicinal products for human and veterinary use.Annex 2: Manufacture of biological active substances and medicinal products for human use //EuropeanCommission[Электронныйресурс].-2013.-Режимдоступа:https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/vol4-an2__2012-06_en.pdf,свободный. – Загл.
с экрана.104. Günther, Ch. Advances in Pharmaceutical Cell Therapy: Principles of Cell-BasedBiopharmaceuticals / Ch. Günther, R. Huss, A. Hauser. - World Scientific, 2016. – P. 524.105. Halme, D.G. FDA regulation of stem-cell–based therapies/ D.G. Halme, D.A. Kessler //NewEngland Journal of Medicine. – 2006. – 355 (16). – P. 1730-1735.106. Health Canada’s Guidance document for cell, tissue and organ establishments safety of humancells, tissues and organs for clinical transplantation// Health Canada [Электронный ресурс]. -1412009. - Режим доступа: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/reg-init/cell/cto_gd_ldeng.php, свободный.
– Загл. с экрана.107. Heathman, T.R.J. The translation of cell-based therapies: clinical landscape and manufacturingchallenges/ Th.R.J. Heathman, A.W. Nienow, M.J. McCall et al. //Regenerative medicine. – 2015.– 10(1). – P. 49-64.108. Herpel, E. Quality management and accreditation of research tissue banks: experience of theNational Center for Tumor Diseases (NCT) Heidelberg/ E. Herpel, Ch.
Röcken, H. Manke et al.//Virchows Archiv. – 2010. – 457(6). – P. 741-747.109. Katari, R. Tissue engineering and regenerative medicine: semantic considerations for an evolvingparadigm/ R. Katari, A. Peloso, G. Orlando //Frontiers in bioengineering and biotechnology. –2015. – 2. – P. 57.110. Kazuo, Y. Regulatory approval for autologous human cells and tissue products in the UnitedStates, the European Union, and Japan/ Y.
Kazuo, W. Natsumi, T. Kenichiro et al. // RegenerativeTherapy. – 2015. – 1. – P. 45–56.111. Kellathur S.N. Cell and tissue therapy regulation: worldwide status and harmonization/ S.N.Kellathur, H.X. Lou //Biologicals - 2012. – 40(3). - P. 222-224.112. Klug, B. Requirements for long-term follow-up on efficacy and safety of advanced therapymedicinal products. Risk management and traceability/ B.
![](https://s.studizba.com/z.php?f=/templates/si/i/noavatar.png&w=100&h=100&t=1"){kind=avatar}
