title: Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccine (part 2).
abstract: The study is a contribution to the EDQM's efforts to meet some of the expectations of the 3 Rs: Replacement, Reduction and Refinement of animal assays as proposed by Russell and Burch in 1959 and adopted by the European Union in 1986, and specifically to validate alternative assays to replace, for batch-release purposes, the European Pharmacopoeia (Ph. Eur.) in vivo direct challenge procedures for the potency determination of diphtheria toxoid vaccines. The study results may be used in support of the replacement of the multi-dilution direct challenge procedures in different animal models by a single dilution serology test, where appropriate, and to use sera from the same animals for potency testing of several components in combined vaccines. With regard to the latter, the present study explores the possibility of testing both diphtheria and tetanus toxoid potencies using serum from the same animals.
authors.affiliation: Norwegian Medicines Agency (NoMA), Oslo, Norway.
authors.forename: R
authors.initials: R
authors.lastname: Winsnes
authors.forename: D
authors.initials: D
authors.lastname: Sesardic
authors.forename: A
authors.initials: A
authors.lastname: Daas
authors.forename: M-E
authors.initials: ME
authors.lastname: Behr-Gross
mesh_terms: D000826:Animal Testing Alternatives / Q000592:standards; D000818:Animals; D002522:Chlorocebus aethiops; D004168:Diphtheria Toxoid / Q000737:chemistry* / Q000276:immunology / Q000592:standards; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000592:standards; D005062:European Union; D006168:Guinea Pigs; D006801:Humans; D009500:Neutralization Tests / Q000592:standards; D010602:Pharmacopoeias as Topic; D012015:Reference Standards; D015203:Reproducibility of Results; D017778:Vaccines, Combined / Q000737:chemistry* / Q000276:immunology / Q000592:standards; D014709:Vero Cells
chemical_list: D004168:Diphtheria Toxoid; D017778:Vaccines, Combined