메뉴 건너뛰기




Volumn 1, Issue 12, 2012, Pages 909-920

Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: Part II-A method of software documentary analysis

Author keywords

Cellular therapy; Clinical translation; Clinical trials; Ethics

Indexed keywords

BIOLOGICAL PRODUCT;

EID: 84872946357     PISSN: 21576564     EISSN: 21576580     Source Type: Journal    
DOI: 10.5966/sctm.2012-0038     Document Type: Article
Times cited : (17)

References (49)
  • 1
    • 33750081777 scopus 로고    scopus 로고
    • FDA regulation of stem-cell-based therapies
    • Halme DG, Kessler DA. FDA regulation of stem-cell-based therapies. N Engl J Med 2006; 355:1730-1735.
    • (2006) N Engl J Med , vol.355 , pp. 1730-1735
    • Halme, D.G.1    Kessler, D.A.2
  • 2
    • 84876511025 scopus 로고    scopus 로고
    • FDA Guidance for industry: PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance, Available at, Accessed January 13, 2011
    • FDA Guidance for industry: PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. 2004. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070305.pdf. Accessed January 13, 2011.
    • (2004)
  • 3
    • 0038222197 scopus 로고    scopus 로고
    • The Financing of Biopharmaceutical Product Development in Europe, European Commission, Enterprise and Industry. October, Available at, Accessed December 5, 2011
    • The Financing of Biopharmaceutical Product Development in Europe. Final Report. European Commission, Enterprise and Industry. October 2009. Available at http://ec.europa.eu/enterprise/sectors/biotechnology/files/docs/financing_biopharma_product_dev_en.pdf. Accessed December 5, 2011.
    • (2009) Final Report
  • 4
    • 84876510293 scopus 로고    scopus 로고
    • Advancing Regulatory Science at FDA, Strategic Plan: August, Food and Drug Administration, U.S. Department of Health and Human Services. Available at, Accessed December 5, 2011
    • Advancing Regulatory Science at FDA, Strategic Plan: August 2011. Food and Drug Administration, U.S. Department of Health and Human Services. Available at http://www.fda.gov/regulatoryscience. Accessed December 5, 2011.
    • (2011)
  • 5
    • 84876509177 scopus 로고    scopus 로고
    • Implementing the European Medicines Agency's Road Map to 2015: The Agency's Contribution to Science, EMA/MB/550544/2011. October 6, Available at, Accessed November 22, 2011
    • Implementing the European Medicines Agency's Road Map to 2015: The Agency's Contribution to Science, Medicine, Health-From Vision to Reality. EMA/MB/550544/2011. October 6, 2011. Available at http://www.ema.europa.eu. Accessed November 22, 2011.
    • (2011) Medicine, Health-From Vision to Reality
  • 6
    • 0142094685 scopus 로고    scopus 로고
    • Current regulatory issues in cell and tissue therapy
    • Burger SR. Current regulatory issues in cell and tissue therapy. Cytotherapy 2003;5:289-298.
    • (2003) Cytotherapy , vol.5 , pp. 289-298
    • Burger, S.R.1
  • 7
    • 85027223865 scopus 로고    scopus 로고
    • TGA basics. Therapeutic Goods Administration. Available at, Accessed September 1
    • TGA basics. Therapeutic Goods Administration. Available at http://www.tga.gov.au/about/tga.htm. Accessed September 1, 2011.
    • (2011)
  • 8
    • 84876511669 scopus 로고    scopus 로고
    • Clinical trials. Therapeutic Goods Administration. Available at, Accessed September 1
    • Clinical trials. Therapeutic Goods Administration. Available at http://www.tga.gov.au/industry/clinical-trials.htm. Accessed September 1, 2011.
    • (2011)
  • 9
    • 84876511778 scopus 로고    scopus 로고
    • Clinical trials at a glance. Therapeutic Goods Administration. Available at, Accessed September 1
    • Clinical trials at a glance. Therapeutic Goods Administration. Available at http://www.tga.gov.au/industry/clinical-trials-glance.htm. Accessed September 1, 2011.
    • (2011)
  • 10
    • 85027226238 scopus 로고    scopus 로고
    • Note for guidance on good clinical practice. Therapeutic Goods Administration. Available at, Accessed August 6
    • Note for guidance on good clinical practice. Therapeutic Goods Administration. Available at http://www.tga.gov.au/industry/clinical-trials-note-ich13595.htm. Accessed August 6, 2011.
    • (2011)
  • 11
    • 84876509077 scopus 로고    scopus 로고
    • European Medicines Agency. Available at, Accessed October 15
    • European Medicines Agency. Available at http://www.ema.europa.eu/ema. Accessed October 15, 2011.
    • (2011)
  • 12
    • 85027235643 scopus 로고    scopus 로고
    • About us. European Medicines Agency. Available at, Accessed October 15
    • About us. European Medicines Agency. Available at http://www.ema.europa.eu/ema/index.jsp?curlpages/about_us/general/general_content_000235.jsp&murlmenus/about_us/about_us.jsp. Accessed October 15, 2011.
    • (2011)
  • 13
    • 84876511161 scopus 로고    scopus 로고
    • Food and Drug Administration. Available at, Accessed October 27
    • Food and Drug Administration. Available at http://www.fda.gov. Accessed October 27, 2011.
    • (2011)
  • 14
    • 84876509867 scopus 로고    scopus 로고
    • Development & Approval Process (CBER). Center for Biologics Evaluation and Research, Food and Drug Administration. Available at, Accessed July 20
    • Development & Approval Process (CBER). Center for Biologics Evaluation and Research, Food and Drug Administration. Available at http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/default.htm. Accessed July 20, 2011.
    • (2011)
  • 15
    • 84876511202 scopus 로고    scopus 로고
    • The Center for Drug Evaluation and Research (CDER), Food and Drug Administration. Guidance, compliance, and regulatory information. Available at, Accessed July 20
    • The Center for Drug Evaluation and Research (CDER), Food and Drug Administration. Guidance, compliance, and regulatory information. Available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm. Accessed July 20, 2011.
    • (2011)
  • 16
    • 84876509066 scopus 로고    scopus 로고
    • New Drug Application (NDA) Process (CBER). Center for Biologics Evaluation and Research, Food and Drug Administration. Available at, Accessed July 21
    • New Drug Application (NDA) Process (CBER). Center for Biologics Evaluation and Research, Food and Drug Administration. Available at http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/NewDrugApplicationNDAProcess/default.htm. Accessed July 21, 2011.
    • (2011)
  • 17
    • 84872922024 scopus 로고    scopus 로고
    • Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: Part I-A method of manual documentary analysis
    • Ilic N, Savic S, Siegel E et al. Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: Part I-A method of manual documentary analysis. STEM CELLS TRANSLATIONAL MEDICINE 2012; 1:898-908.
    • (2012) STEM CELLS TRANSLATIONAL MEDICINE , vol.1 , pp. 898-908
    • Ilic, N.1    Savic, S.2    Siegel, E.3
  • 18
    • 0003899640 scopus 로고    scopus 로고
    • 2nd ed. London, UK: Sage Publications
    • Mason J. Qualitative Researching. 2nd ed. London, UK: Sage Publications, 2002.
    • (2002) Qualitative Researching
    • Mason, J.1
  • 19
    • 85027218293 scopus 로고    scopus 로고
    • Available at, Accessed August 2
    • Smith AE. Leximancer tutorials. Available at https://www.leximancer.com/support/. Accessed August 2, 2011.
    • (2011) Leximancer Tutorials
    • Smith, A.E.1
  • 21
  • 22
    • 65249153873 scopus 로고    scopus 로고
    • Available at, Accessed August 2
    • Smith AE. Leximancer Manual (Version 2.2) 2005. Available at https://www.leximancer.com/wiki/images/7/77/Leximancer_V2_Manual.pdf. Accessed August 2, 2011.
    • (2005) Leximancer Manual (Version 2.2)
    • Smith, A.E.1
  • 23
    • 0003797465 scopus 로고
    • 2nd ed. Thousand Oaks, CA: Sage Publications
    • Weber RP. Basic Content Analysis. 2nd ed. Thousand Oaks, CA: Sage Publications, 1990.
    • (1990) Basic Content Analysis
    • Weber, R.P.1
  • 24
    • 34248710091 scopus 로고    scopus 로고
    • Theories of terminology: Their description, prescription and explanation
    • Cabré Castellví MT. Theories of terminology: Their description, prescription and explanation. Terminology 2003;9:163-199.
    • (2003) Terminology , vol.9 , pp. 163-199
    • Cabré, C.M.T.1
  • 25
    • 55549107704 scopus 로고    scopus 로고
    • Systematic concept analysis within a knowledge-based approach to terminology
    • Wright SE, Buding G, eds, Amsterdam, The Netherlands: John Benjamins
    • Meyer I, Eck K, Skuce D. Systematic concept analysis within a knowledge-based approach to terminology. In: Wright SE, Buding G, eds. Handbook of Terminology Management. Amsterdam, The Netherlands: John Benjamins, 1997:110.
    • (1997) Handbook of Terminology Management , pp. 110
    • Meyer, I.1    Eck, K.2    Skuce, D.3
  • 26
    • 0742308592 scopus 로고
    • Paris: General Information Programme & UNISIST, UNESCO. Paris, France: Infoterm
    • Felber H. Terminology Manual. Paris: General Information Programme & UNISIST, UNESCO. Paris, France: Infoterm, 1984.
    • (1984) Terminology Manual
    • Felber, H.1
  • 28
    • 84876509171 scopus 로고    scopus 로고
    • Regulatory considerations applicable to manufacturing of human placenta-derived mesenchymal stromal cells (MSC) used in clinical trials in Australia and comparison to USA and European regulatory frameworks
    • Springer/Humana Press (in press)
    • Ilic N, Khalil D, Hancock S et al. Regulatory considerations applicable to manufacturing of human placenta-derived mesenchymal stromal cells (MSC) used in clinical trials in Australia and comparison to USA and European regulatory frameworks. Mesenchymal Stem Cell Therapy. Springer/Humana Press (in press).
    • Mesenchymal Stem Cell Therapy
    • Ilic, N.1    Khalil, D.2    Hancock, S.3
  • 29
    • 33748991451 scopus 로고    scopus 로고
    • Evaluation of unsupervised semantic mapping of natural language with Leximancer concept mapping
    • Smith AE, Humphreys MS. Evaluation of unsupervised semantic mapping of natural language with Leximancer concept mapping. Behav Res Methods 2006;38:262-279.
    • (2006) Behav Res Methods , vol.38 , pp. 262-279
    • Smith, A.E.1    Humphreys, M.S.2
  • 30
    • 78650109409 scopus 로고    scopus 로고
    • Conversations between carers and people with schizophrenia: A qualitative analysis using Leximancer
    • Cretchley J, Gallois C, Chenery H et al. Conversations between carers and people with schizophrenia: A qualitative analysis using Leximancer. Qual Health Res 2010;20: 1611-1628.
    • (2010) Qual Health Res , vol.20 , pp. 1611-1628
    • Cretchley, J.1    Gallois, C.2    Chenery, H.3
  • 31
    • 57749159520 scopus 로고    scopus 로고
    • Media-ted political oratory following terrorist events
    • McKenna B, Waddell N. Media-ted political oratory following terrorist events. J Lang Pol 2007;6:377-399.
    • (2007) J Lang Pol , vol.6 , pp. 377-399
    • McKenna, B.1    Waddell, N.2
  • 32
    • 74549178599 scopus 로고    scopus 로고
    • Profiling enterprise risks in large computer companies using the Leximancer software tool
    • Martin NJ, Rice JL. Profiling enterprise risks in large computer companies using the Leximancer software tool. Risk Manag 2007;9: 188-206.
    • (2007) Risk Manag , vol.9 , pp. 188-206
    • Martin, N.J.1    Rice, J.L.2
  • 33
    • 84979924755 scopus 로고    scopus 로고
    • Use of automated content analysis techniques for event image assessment
    • Scott N, Smith AE. Use of automated content analysis techniques for event image assessment. Tourism Recreation Res 2005;30: 87-91.
    • (2005) Tourism Recreation Res , vol.30 , pp. 87-91
    • Scott, N.1    Smith, A.E.2
  • 35
    • 77349127531 scopus 로고    scopus 로고
    • What distinguishes a distinction? Perceptions of quality academic performance and strategies for achieving it
    • Language, and Special Education. Nathan, QLD, Australia: Griffith University
    • Loke K, Bartlett B. What distinguishes a distinction? Perceptions of quality academic performance and strategies for achieving it. In: Reimagining Practice: Researching Change, Vol. 2. Conference Proceedings of the International Conference on Cognition, Language, and Special Education. Nathan, QLD, Australia: Griffith University, 2003; 175-182.
    • (2003) Reimagining Practice: Researching Change, Conference Proceedings of the International Conference On Cognition , vol.2 , pp. 175-182
    • Loke, K.1    Bartlett, B.2
  • 36
    • 77951013958 scopus 로고    scopus 로고
    • Mapping a 40-year history with Leximancer: Themes and concepts in the Journal of Cross-Cultural Psychology
    • Rooney D, Gallois C, Cretchley J. Mapping a 40-year history with Leximancer: Themes and concepts in the Journal of Cross-Cultural Psychology. J Cross-Cultural Psychol 2010;41;318-328.
    • (2010) J Cross-Cultural Psychol , vol.41 , pp. 318-328
    • Rooney, D.1    Gallois, C.2    Cretchley, J.3
  • 37
    • 79958700991 scopus 로고    scopus 로고
    • Communication accommodation and managing musculoskeletal disorders: Doctors' and patients' perspectives
    • Baker SC, Gallois C, Driedger SM et al. Communication accommodation and managing musculoskeletal disorders: doctors' and patients' perspectives. Health Commun 2011;26: 379-388.
    • (2011) Health Commun , vol.26 , pp. 379-388
    • Baker, S.C.1    Gallois, C.2    Driedger, S.M.3
  • 38
    • 58249139115 scopus 로고    scopus 로고
    • Perception of prescription medicine sample packs among Australian professional, government, industry, and consumer organizations, based on automated textual analysis of one-on-one interviews
    • Kyle GJ, Nissen L, Tett S. Perception of prescription medicine sample packs among Australian professional, government, industry, and consumer organizations, based on automated textual analysis of one-on-one interviews. Clin Ther 2008;30:2461-2473.
    • (2008) Clin Ther , vol.30 , pp. 2461-2473
    • Kyle, G.J.1    Nissen, L.2    Tett, S.3
  • 39
    • 65249163551 scopus 로고    scopus 로고
    • Implementation of a patient safety incident management system as viewed by doctors, nurses and allied health professionals
    • Travaglia JF, Westbrook MT, Braithwaite J. Implementation of a patient safety incident management system as viewed by doctors, nurses and allied health professionals. Health (London) 2009;13:277-296.
    • (2009) Health (London) , vol.13 , pp. 277-296
    • Travaglia, J.F.1    Westbrook, M.T.2    Braithwaite, J.3
  • 40
    • 34548088889 scopus 로고    scopus 로고
    • Pathways to help-seeking in bulimia nervosa, binge eating problems: A concept mapping approach
    • Hepworth N, Paxton, SJ. Pathways to help-seeking in bulimia nervosa, binge eating problems: A concept mapping approach. Int J Eat Disord 2007;40:493-504.
    • (2007) Int J Eat Disord , vol.40 , pp. 493-504
    • Hepworth, N.1    Paxton, S.J.2
  • 41
    • 84856209643 scopus 로고    scopus 로고
    • Reactivity and reactions to regulatory transparency in medicine, psychotherapy and counselling
    • McGivern G, Fischer MD. Reactivity and reactions to regulatory transparency in medicine, psychotherapy and counselling. Soc Sci Med 2012;74:289-296.
    • (2012) Soc Sci Med , vol.74 , pp. 289-296
    • McGivern, G.1    Fischer, M.D.2
  • 42
    • 79955374154 scopus 로고    scopus 로고
    • Concept mapping to evaluate an undergraduate pharmacy curriculum
    • Noble C, O'Brien M, Coombes I et al. Concept mapping to evaluate an undergraduate pharmacy curriculum. Am J Pharm Educ 2011;75:55.
    • (2011) Am J Pharm Educ , vol.75 , pp. 55
    • Noble, C.1    O'Brien, M.2    Coombes, I.3
  • 43
    • 33745295674 scopus 로고    scopus 로고
    • Leximancer concept mapping of patient case studies
    • Khosla R, ed., Lecture Notes in Computer Science, Springer
    • Watson M, Smith A, Watter S. Leximancer concept mapping of patient case studies. In: Khosla R, ed. Knowledge-Based Intelligent Information and Engineering Systems. Lecture Notes in Computer Science, Vol. 3683. Springer, 2005;1232-1238.
    • (2005) Knowledge-Based Intelligent Information and Engineering Systems , vol.3683 , pp. 1232-1238
    • Watson, M.1    Smith, A.2    Watter, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.