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; D.B. Morton; E. Charton; J. Cooper; C.F.M. Hendriksen; S. Martin; M.C. Pearce; S. Price; K. Redhead; N. Reed; H. Simmons; S. Spencer; H. Willingale

doi:10.1016/j.biologicals.2010.04.004

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, D.B. Morton, E. Charton, J. Cooper, C.F.M. Hendriksen, S. Martin, M.C. Pearce, S. Price, K. Redhead, N. Reed, H. Simmons, S. Spencer, H. Willingale

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Research output: Contribution to journal › Article › Academic › peer-review

Abstract

This report aims 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 language	English
Pages (from-to)	684-695
Number of pages	12
Journal	Biologicals
Volume	38
Issue number	6
DOIs	https://doi.org/10.1016/j.biologicals.2010.04.004
Publication status	Published - 2010

Keywords

Vaccines
Three Rs
Humane endpoints

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Jennings, M., Morton, D. B., Charton, E., Cooper, J., Hendriksen, C. F. M., Martin, S., Pearce, M. C., Price, S., Redhead, K., Reed, N., Simmons, H., Spencer, S., & Willingale, H. (2010). 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. Biologicals, 38(6), 684-695. https://doi.org/10.1016/j.biologicals.2010.04.004

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Jennings, M, Morton, DB, Charton, E, Cooper, J, Hendriksen, CFM, Martin, S, Pearce, MC, Price, S, Redhead, K, Reed, N, Simmons, H, Spencer, S & Willingale, H 2010, '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', Biologicals, vol. 38, no. 6, pp. 684-695. https://doi.org/10.1016/j.biologicals.2010.04.004

TY - JOUR

T1 - 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

AU - Jennings, M.

AU - Morton, D.B.

AU - Charton, E.

AU - Cooper, J.

AU - Hendriksen, C.F.M.

AU - Martin, S.

AU - Pearce, M.C.

AU - Price, S.

AU - Redhead, K.

AU - Reed, N.

AU - Simmons, H.

AU - Spencer, S.

AU - Willingale, H.

PY - 2010

Y1 - 2010

N2 - This report aims 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.

AB - This report aims 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.

KW - Vaccines

KW - Three Rs

KW - Humane endpoints

U2 - 10.1016/j.biologicals.2010.04.004

DO - 10.1016/j.biologicals.2010.04.004

M3 - Article

SN - 1045-1056

VL - 38

SP - 684

EP - 695

JO - Biologicals

JF - Biologicals

IS - 6

ER -

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

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Keywords

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