메뉴 건너뛰기




Volumn 100, Issue 1, 2011, Pages 34-37

Acceptable levels of endotoxin in vaccine formulations during preclinical research

Author keywords

Endotoxin; Excipients; Formulation; Injectables; Preformulation; Vaccines

Indexed keywords

CHOLERA VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; ENDOTOXIN; INACTIVATED VACCINE; INFLUENZA VACCINE; LIVE VACCINE; MEASLES VACCINE; MUMPS VACCINE; PNEUMOCOCCUS VACCINE; POLIOMYELITIS VACCINE; POLYSACCHARIDE VACCINE; RABIES VACCINE; RECOMBINANT VACCINE; RUBELLA VACCINE; SMALLPOX VACCINE; TETANUS TOXOID; TYPHUS VACCINE;

EID: 78650071105     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22267     Document Type: Article
Times cited : (145)

References (20)
  • 1
    • 49249105174 scopus 로고    scopus 로고
    • Endotoxin limits in formulations for preclinical research
    • Malyala P, Singh M. 2008. Endotoxin limits in formulations for preclinical research. J Pharm Sci 97: 2041-2044.
    • (2008) J Pharm Sci , vol.97 , pp. 2041-2044
    • Malyala, P.1    Singh, M.2
  • 2
    • 85031236791 scopus 로고    scopus 로고
    • FDA., General Biological Products Standards-Purity. Code of Federal Regulations Title 21(610.13).
    • FDA. 2009. General Biological Products Standards-Purity. Code of Federal Regulations Title 21(610.13).
    • (2009)
  • 3
    • 0034965669 scopus 로고    scopus 로고
    • Effects in humans of intravenously administered endotoxin on soluble cell-adhesion molecule and inflammatory markers: A model of human diseases
    • Wilson M, Blum R, Dandona P, Mousa S. 2001. Effects in humans of intravenously administered endotoxin on soluble cell-adhesion molecule and inflammatory markers: A model of human diseases. Clin Exp Pharmacol Physiol 28: 376-380.
    • (2001) Clin Exp Pharmacol Physiol , vol.28 , pp. 376-380
    • Wilson, M.1    Blum, R.2    Dandona, P.3    Mousa, S.4
  • 4
    • 0028063543 scopus 로고
    • Human responses to bacterial endotoxin
    • Burrell R. 1994. Human responses to bacterial endotoxin. Circ Shock 43: 137-153.
    • (1994) Circ Shock , vol.43 , pp. 137-153
    • Burrell, R.1
  • 5
    • 78650048860 scopus 로고    scopus 로고
    • Endotoxins pyrogens, LAL testing and depyrogenation
    • New York: Informa Healthcare.
    • Cooper JF, Williams KL. 2009. Endotoxins pyrogens, LAL testing and depyrogenation. New York: Informa Healthcare.
    • (2009)
    • Cooper, J.F.1    Williams, K.L.2
  • 6
    • 0034735841 scopus 로고    scopus 로고
    • Pyrogenic reactions to gentamicin therapy
    • Fanning MM, Wassel R, Piazza-Hepp T. 2000. Pyrogenic reactions to gentamicin therapy. N Engl J Med 343: 1658-1659.
    • (2000) N Engl J Med , vol.343 , pp. 1658-1659
    • Fanning, M.M.1    Wassel, R.2    Piazza-Hepp, T.3
  • 7
    • 0032561092 scopus 로고    scopus 로고
    • Endotoxin-like reactions associated with intravenous gentamicin-California
    • CDC.
    • CDC. 1998. Endotoxin-like reactions associated with intravenous gentamicin-California. Morb Mortal Wkly Rep 47: 877-880.
    • (1998) Morb Mortal Wkly Rep , vol.47 , pp. 877-880
  • 8
    • 0034294886 scopus 로고    scopus 로고
    • Infant immunization with acellular pertussis vaccines in the United States: Assessment of the first two years' data from the Vaccine Adverse Event Reporting System (VAERS)
    • Braun MM, Mootrey GT, Salive ME, Chen RT, Ellenberg SS. 2000. Infant immunization with acellular pertussis vaccines in the United States: Assessment of the first two years' data from the Vaccine Adverse Event Reporting System (VAERS). Pediatrics 106: E51.
    • (2000) Pediatrics , vol.106
    • Braun, M.M.1    Mootrey, G.T.2    Salive, M.E.3    Chen, R.T.4    Ellenberg, S.S.5
  • 9
    • 0036091087 scopus 로고    scopus 로고
    • Clinical implications of endotoxin concentrations in vaccines
    • Geier DA, Geier MR. 2002. Clinical implications of endotoxin concentrations in vaccines. Ann Pharmacother 36: 776-780.
    • (2002) Ann Pharmacother , vol.36 , pp. 776-780
    • Geier, D.A.1    Geier, M.R.2
  • 10
    • 7944230802 scopus 로고    scopus 로고
    • Mechanistic actions of the risks and adverse events associated with vaccine administration
    • quiz 1021.
    • Moylett EH, Hanson IC. 2004. Mechanistic actions of the risks and adverse events associated with vaccine administration. J Allergy Clin Immunol 114: 1010-1020. quiz 1021.
    • (2004) J Allergy Clin Immunol , vol.114 , pp. 1010-1020
    • Moylett, E.H.1    Hanson, I.C.2
  • 11
    • 78650049059 scopus 로고    scopus 로고
    • Bacterial endotoxins. 60 5.0:2.6.14.
    • Eur. P. 2008. Bacterial endotoxins. 60 5.0:2.6.14.
    • (2008)
    • Eur, P.1
  • 13
    • 0037562893 scopus 로고    scopus 로고
    • Influenza vaccination and Guillain Barre syndrome small star, filled
    • Geier MR, Geier DA, Zahalsky AC. 2003. Influenza vaccination and Guillain Barre syndrome small star, filled. Clin Immunol 107: 116-121.
    • (2003) Clin Immunol , vol.107 , pp. 116-121
    • Geier, M.R.1    Geier, D.A.2    Zahalsky, A.C.3
  • 14
    • 35348988644 scopus 로고    scopus 로고
    • A retrospective study on the quality of Haemophilus influenzae type b vaccines used in the UK between 1996 and 2004
    • Bolgiano B, Mawas F, Burkin K, Crane DT, Saydam M, Rigsby P, Corbel MJ. 2007. A retrospective study on the quality of Haemophilus influenzae type b vaccines used in the UK between 1996 and 2004. Hum Vaccin 3: 176-182.
    • (2007) Hum Vaccin , vol.3 , pp. 176-182
    • Bolgiano, B.1    Mawas, F.2    Burkin, K.3    Crane, D.T.4    Saydam, M.5    Rigsby, P.6    Corbel, M.J.7
  • 16
    • 23844555801 scopus 로고    scopus 로고
    • In vivo humoral immune responses to isolated pneumococcal polysaccharides are dependent on the presence of associated TLR ligands
    • Sen G, Khan AQ, Chen Q, Snapper CM. 2005. In vivo humoral immune responses to isolated pneumococcal polysaccharides are dependent on the presence of associated TLR ligands. J Immunol 175: 3084-3091.
    • (2005) J Immunol , vol.175 , pp. 3084-3091
    • Sen, G.1    Khan, A.Q.2    Chen, Q.3    Snapper, C.M.4
  • 17
    • 44049108096 scopus 로고    scopus 로고
    • Manufacturing and characterizing AAV-based vectors for use in clinical studies
    • Wright JF. 2008. Manufacturing and characterizing AAV-based vectors for use in clinical studies. Gene Ther 15: 840-848.
    • (2008) Gene Ther , vol.15 , pp. 840-848
    • Wright, J.F.1
  • 18
    • 34249942373 scopus 로고    scopus 로고
    • Production of clinical-grade plasmid DNA for human Phase I clinical trials and large animal clinical studies
    • Przybylowski M, Bartido S, Borquez-Ojeda O, Sadelain M, Riviere I. 2007. Production of clinical-grade plasmid DNA for human Phase I clinical trials and large animal clinical studies. Vaccine 25: 5013-5024.
    • (2007) Vaccine , vol.25 , pp. 5013-5024
    • Przybylowski, M.1    Bartido, S.2    Borquez-Ojeda, O.3    Sadelain, M.4    Riviere, I.5
  • 19
    • 85031272609 scopus 로고    scopus 로고
    • FDA., Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies. In Research CfBEa, editor. U.S. Department of Health and Human Services.
    • FDA. 1997. Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies. In Research CfBEa, editor. U.S. Department of Health and Human Services.
    • (1997)
  • 20
    • 0034456936 scopus 로고    scopus 로고
    • Pyrogen sensing and signaling: Old views and new concepts
    • Blatteis Clark M, Sehic E, Li S. 2000. Pyrogen sensing and signaling: Old views and new concepts. Clin Infect Dis 31: S168-S177.
    • (2000) Clin Infect Dis , vol.31
    • Blatteis Clarkâ, M.1    Sehic, E.2    Li, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.