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.
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.
Jennings
Maggy
M
RSPCA, Research Animals Department, Wilberforce Way, Southwater, Horsham, West Sussex RH13 9RS, UK. mjennings@rspca.org.uk
Morton
David B
DB
Charton
Emmanuelle
E
Cooper
Jane
J
Hendriksen
Coenraad
C
Martin
Stella
S
Pearce
Michael C
MC
Price
Scott
S
Redhead
Keith
K
Reed
Nick
N
Simmons
Hugh
H
Spencer
Stephen
S
Willingale
Hilary
H
D000818:Animals; D014612:Vaccines / Q000008:administration & dosage / Q000276:immunology* / Q000627:therapeutic use; D014730:Veterinary Medicine
D014612:Vaccines