Application of the Three Rs to challenge assays used in vaccine testing Tenth report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement

M Jennings, David Morton, E Charton, J Cooper, C Hendriksen, S Martin, MC Pearce, S Price, K Redhead, N Reed, H Simmons, S Spencer, H Willingale

    Research output: Contribution to journalArticle

    12 Citations (Scopus)

    Abstract

    This report alms to facilitate the implementation of the Three Rs (reduction refinement and replacement) in the testing of vaccines for regulatory and other purposes The focus is predominantly on identification of reduction and refinement opportunities in batch potency testing but the principles described are widely applicable to other situations that involve experimental infections of animals The report should also help to interpret the requirements of the European Pharmacopoeia with regard to the use of alternative tests humane endpoints and other refinements Two specific worked examples for batch potency testing of Clostridium chauvoei and canine leptospira with recommendations for harmonisation of international test requirements for these and other vaccines are provided as appendices online
    Original languageEnglish
    Pages (from-to)684-695
    Number of pages12
    JournalBiologicals
    Volume38
    Issue number6
    DOIs
    Publication statusPublished - 1 Nov 2010

    Keywords

    • Humane endpoints
    • Vaccines
    • Three Rs
    • Guideline harmonisation

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