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Volumn 27, Issue SUPPL. 4, 2009, Pages

Development pathway for biodefense vaccines

Author keywords

Biodefense; Vaccine development

Indexed keywords

VACCINE;

EID: 79952223316     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.07.094     Document Type: Article
Times cited : (9)

References (32)
  • 1
    • 1842834239 scopus 로고    scopus 로고
    • The costs and economics of modern vaccine development
    • Batson A. The costs and economics of modern vaccine development. Dev Biol 2002;110:15-24.
    • (2002) Dev Biol , vol.110 , pp. 15-24
    • Batson, A.1
  • 2
    • 0029927993 scopus 로고    scopus 로고
    • Vaccine research and product development success rates and development times
    • Struck MM. Vaccine research and product development success rates and development times. Nat Biotechnol 1996;14:591-3.
    • (1996) Nat Biotechnol , vol.14 , pp. 591-593
    • Struck, M.M.1
  • 3
    • 20044362792 scopus 로고    scopus 로고
    • The problems and promise of vaccine markets in developing countries
    • Batson A. The problems and promise of vaccine markets in developing countries. Health Affairs 2005;24:690-3.
    • (2005) Health Affairs , vol.24 , pp. 690-693
    • Batson, A.1
  • 4
    • 27944490850 scopus 로고    scopus 로고
    • Anticipating crisis: towards a pandemic flu vaccination strategy through alignment of public health and industrial policy
    • December
    • Daems R, Del Giudice G, Rappuoli R. Anticipating crisis: towards a pandemic flu vaccination strategy through alignment of public health and industrial policy. Vaccine 2005;23(December (50)):5732-42.
    • (2005) Vaccine , vol.23 , Issue.50 , pp. 5732-5742
    • Daems, R.1    Del Giudice, G.2    Rappuoli, R.3
  • 5
    • 36849091434 scopus 로고    scopus 로고
    • Bridging the knowledge gaps in vaccine design
    • Rappuoli R. Bridging the knowledge gaps in vaccine design. Nat Biotechnol 2007;25(12):1361-6.
    • (2007) Nat Biotechnol , vol.25 , Issue.12 , pp. 1361-1366
    • Rappuoli, R.1
  • 6
    • 84946457886 scopus 로고
    • The impact of new technologies on vaccine development
    • Winther MD, Dougan G. The impact of new technologies on vaccine development. Biotechnol Genet Eng Rev 1984;2:1-39.
    • (1984) Biotechnol Genet Eng Rev , vol.2 , pp. 1-39
    • Winther, M.D.1    Dougan, G.2
  • 7
    • 0023273504 scopus 로고
    • Safety and immunogenicity of a purified hepatitis B virus vaccine prepared by using recombinant DNA technology
    • Zahradnik JM, Couch RB, Gerin JL. Safety and immunogenicity of a purified hepatitis B virus vaccine prepared by using recombinant DNA technology. J Infect Dis 1987;155:903-8.
    • (1987) J Infect Dis , vol.155 , pp. 903-908
    • Zahradnik, J.M.1    Couch, R.B.2    Gerin, J.L.3
  • 8
    • 33646421976 scopus 로고    scopus 로고
    • Prophylactic human papillomavirus vaccines
    • May
    • Lowy DR, Schiller JT. Prophylactic human papillomavirus vaccines. J Clin Invest 2006;116(May (5)):1167-73.
    • (2006) J Clin Invest , vol.116 , Issue.5 , pp. 1167-1173
    • Lowy, D.R.1    Schiller, J.T.2
  • 9
    • 79952205308 scopus 로고    scopus 로고
    • http://www.fda.gov/Cber/gdlns/vaccsubstrates.pdf.
  • 10
    • 79952207732 scopus 로고    scopus 로고
    • http://www.scribd.com/doc/2761067/Notice-Reports-and-guidancedocuments-availability-etc-Plasmid-deoxyribonucleic-acid-DNA-vaccinesconsiderations-for-infectious-disease-indica.
  • 11
    • 79952209267 scopus 로고    scopus 로고
    • http://www.fda.gov/ora/complianceref/bimo/glp/default.htm.
  • 12
    • 0037093627 scopus 로고    scopus 로고
    • Non-clinical vaccine safety assessment
    • Verdier F. Non-clinical vaccine safety assessment. Toxicology 2002;174:37-43.
    • (2002) Toxicology , vol.174 , pp. 37-43
    • Verdier, F.1
  • 13
    • 0037392978 scopus 로고    scopus 로고
    • Reproductive toxicity testing of vaccines
    • Verdier F, Barrow PC, Burge J. Reproductive toxicity testing of vaccines. Toxicology 2003;185:213-9.
    • (2003) Toxicology , vol.185 , pp. 213-219
    • Verdier, F.1    Barrow, P.C.2    Burge, J.3
  • 14
    • 17044439020 scopus 로고    scopus 로고
    • Non-clinical safety evaluation of novel vaccines and adjuvants: new products, new strategies
    • Brennan FR, Dougan G. Non-clinical safety evaluation of novel vaccines and adjuvants: new products, new strategies. Vaccine 2005;23:3210-22.
    • (2005) Vaccine , vol.23 , pp. 3210-3222
    • Brennan, F.R.1    Dougan, G.2
  • 15
    • 57849085182 scopus 로고    scopus 로고
    • Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans
    • Querec TD, Akondy RS, Lee EK, Cao W, Nakaya HI, Teuwen D, et al. Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nat Immunol 2009;10(1):116-25.
    • (2009) Nat Immunol , vol.10 , Issue.1 , pp. 116-125
    • Querec, T.D.1    Akondy, R.S.2    Lee, E.K.3    Cao, W.4    Nakaya, H.I.5    Teuwen, D.6
  • 16
    • 79952239359 scopus 로고    scopus 로고
    • http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm.
  • 17
    • 79952210245 scopus 로고    scopus 로고
    • http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf.
  • 18
    • 79952212134 scopus 로고    scopus 로고
    • http://www.fda.gov/OHRMS/DOCKETS/98fr/053102a.htm.
  • 19
    • 26944502411 scopus 로고    scopus 로고
    • HHS. Registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
    • Food and Drug Administration
    • Food and Drug Administration. HHS. Registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule. Fed Regist 2005;70:57505-9.
    • (2005) Final rule. Fed Regist , vol.70 , pp. 57505-57509
  • 20
    • 79952207518 scopus 로고    scopus 로고
    • http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078923.pdf.
  • 21
    • 1842834215 scopus 로고    scopus 로고
    • Development of vaccines for bio-warfare agents
    • Rosenthal SR, Clifford JC. Development of vaccines for bio-warfare agents. Dev Biol (Basel) 2002;110:99-105.
    • (2002) Dev Biol (Basel) , vol.110 , pp. 99-105
    • Rosenthal, S.R.1    Clifford, J.C.2
  • 22
    • 35148881612 scopus 로고    scopus 로고
    • Alliance for biosecurity The FDA animal efficacy rule and biodefense
    • Gronvall GK, Trent D, Borio L, Brey R, Nagao L. Alliance for biosecurity. The FDA animal efficacy rule and biodefense. Nat Biotechnol 2007;25:1084-7.
    • (2007) Nat Biotechnol , vol.25 , pp. 1084-1087
    • Gronvall, G.K.1    Trent, D.2    Borio, L.3    Brey, R.4    Nagao, L.5
  • 23
    • 2942637954 scopus 로고    scopus 로고
    • Regulation of vaccines: strengthening the science base
    • Milstien JB. Regulation of vaccines: strengthening the science base. J Public Health Policy 2004;25:173-89.
    • (2004) J Public Health Policy , vol.25 , pp. 173-189
    • Milstien, J.B.1
  • 24
    • 33746927104 scopus 로고    scopus 로고
    • The impact of globalization on vaccine development and availability
    • Milstien JB, Kaddar M, Kieny MP. The impact of globalization on vaccine development and availability. Health Affairs 2006;25:1061-9.
    • (2006) Health Affairs , vol.25 , pp. 1061-1069
    • Milstien, J.B.1    Kaddar, M.2    Kieny, M.P.3
  • 26
    • 0029187762 scopus 로고
    • Regulatory considerations in vaccine design
    • Davenport LW. Regulatory considerations in vaccine design. Pharm Biotechnol 1995;6:81-96.
    • (1995) Pharm Biotechnol , vol.6 , pp. 81-96
    • Davenport, L.W.1
  • 27
    • 11144244446 scopus 로고    scopus 로고
    • Vaccine INDs: review of clinical holds
    • Miller DL, Ross JJ. Vaccine INDs: review of clinical holds. Vaccine 2005;23:1099-101.
    • (2005) Vaccine , vol.23 , pp. 1099-1101
    • Miller, D.L.1    Ross, J.J.2
  • 28
    • 0003497355 scopus 로고    scopus 로고
    • FDA (CBER)., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), April
    • FDA (CBER). Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), April 1996.
    • (1996) Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance. U.S.
  • 29
    • 79952234472 scopus 로고    scopus 로고
    • http://www.fda.gov/Cber/regsopp/8401.htm.
  • 30
    • 79952235075 scopus 로고    scopus 로고
    • http://www.who.int/entity/biologicals/publications/trs/areas/vaccines/en/.
  • 31
    • 79952220576 scopus 로고    scopus 로고
    • http://www.cdc.gov/vaccinesafety/vaers/.
  • 32
    • 10844237302 scopus 로고    scopus 로고
    • Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the vaccine adverse event reporting system (VAERS)
    • Sever JL, Brenner AI, Gale AD, Lyle JM, Moulton LH, Ward BJ, et al. Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the vaccine adverse event reporting system (VAERS). Pharmacoepidemiol Drug Saf 2004;13(12):825-40.
    • (2004) Pharmacoepidemiol Drug Saf , vol.13 , Issue.12 , pp. 825-840
    • Sever, J.L.1    Brenner, A.I.2    Gale, A.D.3    Lyle, J.M.4    Moulton, L.H.5    Ward, B.J.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.