Would an in vitro ELISA test be a suitable alternative potency method to the in vivo immunogenicity assay commonly used in the context of international Hepatitis A vaccines batch release?

Vaccine

Volumn 28, Issue 7, 2010, Pages 1796-1802

  Poirier, Bertrand ^a   Variot, Pascale ^a   Delourme, Pauline ^b   Maurin, Jacques ^b   Morgeaux, Sylvie ^a  

^a AFSSAPS   (France)

^b Site de Montpellier Vendargues   (France)

Author keywords

3R's; Alternative method; Correlation; ELISA; Hepatitis A vaccine control; In vivo potency assay; Replace; Statistics

Indexed keywords

HEPATITIS A ANTIGEN; HEPATITIS C VACCINE; IMMUNOGLOBULIN G; IMMUNOGLOBULIN G3K; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG POTENCY; DRUG RELEASE; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HEPATITIS C; IMMUNOGENICITY; IN VITRO STUDY; IN VIVO STUDY; NONHUMAN; PRIORITY JOURNAL;

ANIMAL TESTING ALTERNATIVES; ANIMALS; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HEPATITIS A VACCINES; MICE;

EID: 75449115137     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.12.006     Document Type: Article

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