{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,20]],"date-time":"2025-10-20T10:18:09Z","timestamp":1760955489821},"reference-count":48,"publisher":"Elsevier BV","issue":"4","license":[{"start":{"date-parts":[[2014,7,1]],"date-time":"2014-07-01T00:00:00Z","timestamp":1404172800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"funder":[{"name":"Doerenkamp-Zbinden Foundation"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Biologicals"],"published-print":{"date-parts":[[2014,7]]},"DOI":"10.1016\/j.biologicals.2014.04.001","type":"journal-article","created":{"date-parts":[[2014,5,14]],"date-time":"2014-05-14T21:15:17Z","timestamp":1400102117000},"page":"205-217","update-policy":"http:\/\/dx.doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":21,"title":["Replacing the NIH test for rabies vaccine potency testing: A synopsis of drivers and barriers"],"prefix":"10.1016","volume":"42","author":[{"given":"Marie-Jeanne","family":"Schiffelers","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bas","family":"Blaauboer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wieger","family":"Bakker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Coenraad","family":"Hendriksen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.biologicals.2014.04.001_bib1","doi-asserted-by":"crossref","first-page":"232","DOI":"10.1016\/j.provac.2011.10.024","article-title":"Application of the consistency approach to reduce animal use in vaccine potency testing","volume":"5","author":"Kulpa-Eddy","year":"2011","journal-title":"Proc Vaccinol"},{"year":"2011","series-title":"Vaccines, animal experiments and alternatives: a survey of reduction, refinement and replacement strategies in human and veterinary development, production and quality control","author":"Hoonakker","key":"10.1016\/j.biologicals.2014.04.001_bib2"},{"key":"10.1016\/j.biologicals.2014.04.001_bib3","doi-asserted-by":"crossref","first-page":"414","DOI":"10.3390\/ani1040414","article-title":"Bridging the gap between validation and implementation of non-animal veterinary vaccine potency testing methods","volume":"1","author":"Dozier","year":"2011","journal-title":"Animals"},{"year":"1959","series-title":"The principles of humane experimental technique","author":"Russell","key":"10.1016\/j.biologicals.2014.04.001_bib4"},{"key":"10.1016\/j.biologicals.2014.04.001_bib5","first-page":"429","article-title":"Three Rs approaches in the quality control of inactivated rabies vaccines","volume":"31","author":"Bruckner","year":"2003","journal-title":"ATLA"},{"key":"10.1016\/j.biologicals.2014.04.001_bib6","doi-asserted-by":"crossref","first-page":"100","DOI":"10.1016\/j.biologicals.2011.10.004","article-title":"Potency testing of veterinary vaccines: the way from in\u00a0vivo to in\u00a0vitro","volume":"40","author":"Romberg","year":"2012","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib7","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1016\/j.provac.2011.10.003","article-title":"Improving animal welfare and reducing animal use for human vaccine potency testing: state of the science and future directions","volume":"5","author":"Casey","year":"2011","journal-title":"Proc Vaccinol"},{"key":"10.1016\/j.biologicals.2014.04.001_bib8","article-title":"Case study research: design and methods","volume":"vol. 5","author":"Yin","year":"2003"},{"key":"10.1016\/j.biologicals.2014.04.001_bib9","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1016\/j.biologicals.2010.12.001","article-title":"The consistency approach for quality control of vaccines \u2013 a strategy to improve quality control and implement 3Rs","volume":"39","author":"De Mattia","year":"2011","journal-title":"Biologicals"},{"volume":"vol. 134","article-title":"Potency testing of veterinary vaccines for animals: the way from in\u00a0vivo to in\u00a0vitro","year":"2012","key":"10.1016\/j.biologicals.2014.04.001_bib10"},{"key":"10.1016\/j.biologicals.2014.04.001_bib11","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.provac.2011.10.001","article-title":"Introduction and summary of the international workshop on alternative methods to reduce, re\ufb01ne, and replace the use of animals in vaccine potency and safety testing: state of the science and future directions","volume":"5","author":"Stokes","year":"2011","journal-title":"Proc Vaccinol"},{"key":"10.1016\/j.biologicals.2014.04.001_bib12","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1016\/j.biologicals.2012.07.005","article-title":"Report on the international workshop on alternative methods for human and veterinary rabies vaccine testing: state of the science and planning the way forward","volume":"40","author":"Stokes","year":"2012","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib13","first-page":"4","article-title":"In\u00a0vivo potency tests of rabies inactivated vaccines for veterinary use: a 2-year retrospective analysis of data according to the criteria of the European Pharmacopoeia","volume":"20","author":"Servat","year":"2008","journal-title":"Pharmeuropa"},{"key":"10.1016\/j.biologicals.2014.04.001_bib14","doi-asserted-by":"crossref","first-page":"287","DOI":"10.14573\/altex.2012.3.287","article-title":"Regulatory acceptance and use of 3R models: a multilevel perspective","volume":"3","author":"Schiffelers","year":"2012","journal-title":"ALTEX"},{"key":"10.1016\/j.biologicals.2014.04.001_bib15","doi-asserted-by":"crossref","first-page":"251","DOI":"10.1016\/S0040-1625(96)00180-1","article-title":"The past and future of constructive technology assessment","volume":"54","author":"Schot","year":"1996","journal-title":"Technol Forecast Soc Change"},{"key":"10.1016\/j.biologicals.2014.04.001_bib16","series-title":"Understanding industrial transformation: views from different disciplines","first-page":"163","article-title":"Multi-level perspective on system innovation: relevance for industrial transformation","author":"Geels","year":"2006"},{"key":"10.1016\/j.biologicals.2014.04.001_bib17","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1007\/s10368-010-0163-y","article-title":"The Dutch energy transition approach","volume":"7","author":"Kemp","year":"2010","journal-title":"Int Econ Econ Policy"},{"year":"1995","series-title":"Agendas, alternatives and public policies","author":"Kingdon","key":"10.1016\/j.biologicals.2014.04.001_bib18"},{"key":"10.1016\/j.biologicals.2014.04.001_bib19","doi-asserted-by":"crossref","first-page":"1257","DOI":"10.1016\/S0048-7333(02)00062-8","article-title":"Technological transitions as evolutionary configuration processes: a multi-level perspective and a case study","volume":"31","author":"Geels","year":"2002","journal-title":"Res Policy"},{"key":"10.1016\/j.biologicals.2014.04.001_bib20","series-title":"Laboratory techniques in rabies","first-page":"354","article-title":"A\u00a0rapid tissue culture test for determining rabies neutralizing antibody","author":"Smith","year":"1996"},{"key":"10.1016\/j.biologicals.2014.04.001_bib21","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1016\/S0022-1759(97)00212-3","article-title":"Development of a fluorescent antibody virus neutralization test (FAVN test) for the quantitation of rabies-neutralizing antibody","volume":"212","author":"Cliquet","year":"1998","journal-title":"J\u00a0Immunol"},{"key":"10.1016\/j.biologicals.2014.04.001_bib22","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1016\/j.biologicals.2009.01.001","article-title":"The rapid fluorescent focus inhibition test is a suitable method for batch potency testing of inactivated rabies vaccines","volume":"37","author":"Kr\u00e4mer","year":"2009","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib23","first-page":"37","article-title":"Collaborative study for validation of a serological potency assay for rabies vaccine (inactivated) for veterinary use","volume":"2","author":"Kr\u00e4mer","year":"2010","journal-title":"Pharmeur Biol Sci Notes"},{"year":"2013","series-title":"Rabies vaccine (inactivated) for veterinary use. Ph. Eur","author":"European Pharmacopoeia Monograph 04\/2013:0451","key":"10.1016\/j.biologicals.2014.04.001_bib24"},{"key":"10.1016\/j.biologicals.2014.04.001_bib25","first-page":"283","article-title":"A\u00a0collaborative study on the use of single radial immunodiffusion for the assay of rabies virus glycoprotein","volume":"13","author":"Ferguson","year":"1984","journal-title":"J\u00a0Biol Stand"},{"key":"10.1016\/j.biologicals.2014.04.001_bib26","series-title":"Laboratory techniques in rabies","first-page":"292","article-title":"The antibody binding test for vaccine potency","author":"Arko","year":"1973"},{"key":"10.1016\/j.biologicals.2014.04.001_bib27","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1016\/1045-1056(90)90037-Z","article-title":"In\u00a0vitro rabies vaccine potency appraisal by ELISA: advantages of the immunocapture method with a neutralizing anti-glycoprotein monoclonal antibody","volume":"18","author":"Perrin","year":"1990","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib28","first-page":"137","article-title":"Development and evaluation of alternative testing methods for the in\u00a0vivo NIH potency test used for the quality control of inactivated rabies vaccines","volume":"86","author":"Rooijakkers","year":"1996","journal-title":"Dev Biol Stand"},{"key":"10.1016\/j.biologicals.2014.04.001_bib29","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1006\/biol.1996.0012","article-title":"Use of ELISA for in\u00a0vitro potency test of rabies vaccines for animal use","volume":"24","author":"Gamoh","year":"1996","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib30","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1016\/S1045-1056(05)80062-4","article-title":"Report of a collaborative study to assess the determination of glycoprotein antigen content of rabies vaccines for human use","volume":"20","author":"Ferguson","year":"1992","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib31","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/S1045-1056(02)00070-2","article-title":"Inactivated rabies vaccine control and release: use of an ELISA method","volume":"31","author":"Fournier-Caruana","year":"2003","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib32","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1016\/j.yrtph.2014.02.007","article-title":"Regulatory acceptance and use of 3R models for pharmaceuticals and chemicals: expert opinions on the state of affairs and the way forward","volume":"69","author":"Schiffelers","year":"2014","journal-title":"Regul Toxicol Pharmacol"},{"key":"10.1016\/j.biologicals.2014.04.001_bib33","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1016\/0264-410X(88)90185-5","article-title":"NIH test, a problematic method for testing potency of inactivated rabies vaccine","volume":"6","author":"Barth","year":"1988","journal-title":"Vaccine"},{"key":"10.1016\/j.biologicals.2014.04.001_bib34","doi-asserted-by":"crossref","first-page":"164","DOI":"10.1016\/j.provac.2011.10.015","article-title":"International regulatory requirements for vaccine safety and potency testing: a WHO perspective","volume":"5","author":"Shin","year":"2011","journal-title":"Proc Vaccinol"},{"key":"10.1016\/j.biologicals.2014.04.001_bib35","doi-asserted-by":"crossref","first-page":"7115","DOI":"10.1016\/j.vaccine.2006.06.078","article-title":"The rabies peripheral challenge test: more accurate determination of vaccine potency","volume":"24","author":"Wunderli","year":"2006","journal-title":"Vaccine"},{"key":"10.1016\/j.biologicals.2014.04.001_bib36","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1016\/j.biologicals.2009.08.004","article-title":"Stability evaluation of vaccines; WHO approach","volume":"37","author":"Knezevic","year":"2009","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib37","doi-asserted-by":"crossref","first-page":"412","DOI":"10.1016\/j.biologicals.2009.08.002","article-title":"A\u00a0vaccine measured with a highly variable assay: rabies","volume":"37","author":"Jivapaisarnpong","year":"2009","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib38","doi-asserted-by":"crossref","first-page":"73","DOI":"10.1016\/j.biologicals.2007.05.002","article-title":"The consistency approach for the quality control of vaccines","volume":"36","author":"Hendriksen","year":"2008","journal-title":"Biologicals"},{"year":"2011","series-title":"Rabies vaccine for human use prepared in cell cultures. Ph. Eur","author":"European Pharmacopoeia Monograph 04\/2008:0216","key":"10.1016\/j.biologicals.2014.04.001_bib39"},{"key":"10.1016\/j.biologicals.2014.04.001_bib40","unstructured":"U.S. Code of Federal Regulations, Title 9, Chapter I: animal and plant health inspection service, Department of Agriculture, Subchapter E \u2013 viruses, serums, toxins, and analogous products; organisms and vectors, Part 113.209,rabies vaccine, killed virus. Washington D.C., USA: U.S. Government Printing Office; updated 2010."},{"year":"2007","series-title":"Center for veterinary biologics, code of Federal regulations, Title 9, animals and animal products","author":"United States Department of Agriculture","key":"10.1016\/j.biologicals.2014.04.001_bib41"},{"key":"10.1016\/j.biologicals.2014.04.001_bib42","first-page":"83","article-title":"Annex 2: recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs","volume":"vol. 941","author":"WHO","year":"2007"},{"key":"10.1016\/j.biologicals.2014.04.001_bib43","series-title":"Manual of standards for diagnostic tests and vaccines for terrestrial animals","first-page":"276","article-title":"Rabies","author":"OIE","year":"2012"},{"key":"10.1016\/j.biologicals.2014.04.001_bib44","doi-asserted-by":"crossref","first-page":"184","DOI":"10.1016\/j.provac.2011.10.018","article-title":"A\u00a0case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency","volume":"5","author":"Descamps","year":"2011","journal-title":"Proc Vaccinol"},{"key":"10.1016\/j.biologicals.2014.04.001_bib45","first-page":"33","article-title":"Directive 2010\/63\/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes","volume":"276","author":"European Commission","year":"2010","journal-title":"Off J Eur Union L"},{"key":"10.1016\/j.biologicals.2014.04.001_bib46","doi-asserted-by":"crossref","first-page":"684","DOI":"10.1016\/j.biologicals.2010.04.004","article-title":"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","volume":"38","author":"Jennings","year":"2010","journal-title":"Biologicals"},{"key":"10.1016\/j.biologicals.2014.04.001_bib47","first-page":"179","article-title":"Veel kunnen verklaren of iets kunnen veranderen: krachtige versus manipuleerbare variabelen","volume":"3","author":"Ellemers","year":"1979","journal-title":"Beleid en Maatschappij"},{"key":"10.1016\/j.biologicals.2014.04.001_bib48","doi-asserted-by":"crossref","first-page":"418","DOI":"10.1016\/j.yrtph.2012.05.006","article-title":"Challenges and opportunities for the implementation of the 3Rs in Canadian vaccine quality control","volume":"63","author":"Long","year":"2012","journal-title":"Regul Toxicol Pharmacol"}],"container-title":["Biologicals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1045105614000232?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1045105614000232?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2018,10,4]],"date-time":"2018-10-04T01:03:21Z","timestamp":1538615001000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1045105614000232"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,7]]},"references-count":48,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2014,7]]}},"alternative-id":["S1045105614000232"],"URL":"https:\/\/doi.org\/10.1016\/j.biologicals.2014.04.001","relation":{},"ISSN":["1045-1056"],"issn-type":[{"type":"print","value":"1045-1056"}],"subject":[],"published":{"date-parts":[[2014,7]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Replacing the NIH test for rabies vaccine potency testing: A synopsis of drivers and barriers","name":"articletitle","label":"Article Title"},{"value":"Biologicals","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.biologicals.2014.04.001","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2014 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.","name":"copyright","label":"Copyright"}]}}