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Volumn 32, Issue 4, 2004, Pages 171-176

Comparison between in vitro potency tests for Cuban Hepatitis B vaccine: Contribution to the standardization process

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS B VACCINE;

EID: 9644302348     PISSN: 10451056     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.biologicals.2004.03.003     Document Type: Article
Times cited : (10)

References (15)
  • 1
    • 0029686526 scopus 로고    scopus 로고
    • Requirements for valid alternative assays for testing of biological therapeutic agents
    • D. Sesardic Requirements for valid alternative assays for testing of biological therapeutic agents Development in Biological Standardization 86 1996 311 318
    • (1996) Development in Biological Standardization , vol.86 , pp. 311-318
    • Sesardic, D.1
  • 2
    • 2542635812 scopus 로고    scopus 로고
    • Validation of alternative methods for the potency testing of vaccines. The report and recommendations of ECVAM workshop 3l
    • C.F.M. Hendriksen Validation of alternative methods for the potency testing of vaccines. The report and recommendations of ECVAM workshop 3l ATLA 26 2001 747 761
    • (2001) ATLA , vol.26 , pp. 747-761
    • Hendriksen, C.F.M.1
  • 3
    • 0002719307 scopus 로고
    • Alternatives to animal testing in the quality control of immunobiologicals: Current status and future prospects. The report and recommendations of ECVAM workshop 4
    • C.F.M. Hendriksen Alternatives to animal testing in the quality control of immunobiologicals: current status and future prospects. The report and recommendations of ECVAM workshop 4 ATLA 22 1994 420 434
    • (1994) ATLA , vol.22 , pp. 420-434
    • Hendriksen, C.F.M.1
  • 4
    • 0005516065 scopus 로고    scopus 로고
    • Assuring the quality of vaccines: Regulatory requirements for licensing and batch release
    • A. Robinson Humana Press Totowa, NJ, USA
    • E. Griffith Assuring the quality of vaccines: regulatory requirements for licensing and batch release A. Robinson Methods in molecular medicine: vaccine protocols 1996 Humana Press Totowa, NJ, USA 269 288
    • (1996) Methods in Molecular Medicine: Vaccine Protocols , pp. 269-288
    • Griffith, E.1
  • 5
    • 9644264484 scopus 로고    scopus 로고
    • Annex 4: Requirements for hepatitis B vaccines made by recombinant DNA techniques
    • WHO Annex 4: requirements for hepatitis B vaccines made by recombinant DNA techniques WHO technical report series 889 1999 p. 94-5
    • (1999) WHO Technical Report Series 889
    • Who1
  • 7
    • 0025672575 scopus 로고
    • Report of a collaborative study for assessing the potency of Hepatitis B vaccines
    • M. Ferguson Report of a collaborative study for assessing the potency of Hepatitis B vaccines Biologicals 18 1990 345 350
    • (1990) Biologicals , vol.18 , pp. 345-350
    • Ferguson, M.1
  • 8
    • 9644262975 scopus 로고    scopus 로고
    • Collaborative study for the establishment of biological reference preparations for rDNA hepatitis B vaccine
    • R. Dobbelaer Collaborative study for the establishment of biological reference preparations for rDNA hepatitis B vaccine Pharmeuropa Special 97 2 1997 3 18
    • (1997) Pharmeuropa Special , vol.97 , Issue.2 , pp. 3-18
    • Dobbelaer, R.1
  • 9
    • 0037631377 scopus 로고    scopus 로고
    • Validation of an in vitro potency test for Cuban Hepatitis B vaccine in the NCL
    • M.L. Chovel, and N. Reyes Validation of an in vitro potency test for Cuban Hepatitis B vaccine in the NCL Development in Biologicals 111 2002 307 315
    • (2002) Development in Biologicals , vol.111 , pp. 307-315
    • Chovel, M.L.1    Reyes, N.2
  • 10
    • 9644256202 scopus 로고    scopus 로고
    • Validation of an in vitro test for Hepatitis B vaccine
    • Izquierdo M y cols Validation of an in vitro test for Hepatitis B vaccine Biotechnology 2001 18
    • (2001) Biotechnology , pp. 18
    • Et Al.s Izquierdo, M.1
  • 13
    • 84862473191 scopus 로고
    • Validación de los procedimientos analíticos empleados en el examen de los materials farmacéuticos
    • OMS Ginebra
    • Comité de Expertos de la OMS en Especificaciones para las Preparaciones Farmacéuticas Validación de los procedimientos analíticos empleados en el examen de los materials farmacéuticos Serie de Informes Técnicos No 823 Anexo 5 1992 OMS Ginebra
    • (1992) Serie de Informes Técnicos No 823 Anexo 5
  • 14
    • 0001149111 scopus 로고
    • The validation of alternative test method
    • M. Balls The validation of alternative test method ATLA 23 1995 884 886
    • (1995) ATLA , vol.23 , pp. 884-886
    • Balls, M.1
  • 15
    • 0002570977 scopus 로고
    • Validation of immunological and biological assays
    • Laureen E. Little Validation of immunological and biological assays BioPharm 1995 36 42
    • (1995) BioPharm , pp. 36-42
    • Little Laureen, E.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.