{"id":"https://openalex.org/W2016164331","doi":"https://doi.org/10.1039/c2tx20011b","title":"Validation and quality control of replacement alternatives \u2013 current status and future challenges","display_name":"Validation and quality control of replacement alternatives \u2013 current status and future challenges","publication_year":2012,"publication_date":"2012-05-11","ids":{"openalex":"https://openalex.org/W2016164331","doi":"https://doi.org/10.1039/c2tx20011b","mag":"2016164331"},"language":"en","primary_location":{"id":"doi:10.1039/c2tx20011b","doi":"https://doi.org/10.1039/c2tx20011b","is_oa":false,"landing_page_url":"https://doi.org/10.1039/c2tx20011b","pdf_url":null,"source":{"id":"https://openalex.org/S2494971184","display_name":"Toxicology Research","issn_l":"2045-452X","issn":["2045-452X","2045-4538"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-d","ki-jl-1","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Toxicology Research","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5022661690","display_name":"Marcel Leist","orcid":"https://orcid.org/0000-0002-3778-8693","observed_orcids":["https://orcid.org/0000-0002-3778-8693"]},"institutions":[{"id":"https://openalex.org/I189712700","display_name":"University of Konstanz","ror":"https://ror.org/0546hnb39","country_code":"DE","type":"education","lineage":["https://openalex.org/I189712700"]}],"countries":["DE"],"is_corresponding":true,"raw_author_name":"Marcel Leist","raw_affiliation_strings":["Doerenkamp-Zbinden Chair for In-vitro Toxicology and Biomedicine and Center for Alternatives to Animal Testing in Europe (CAAT-Europe), University of Konstanz, D-78467 Konstanz, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Doerenkamp-Zbinden Chair for In-vitro Toxicology and Biomedicine and Center for Alternatives to Animal Testing in Europe (CAAT-Europe), University of Konstanz, D-78467 Konstanz, Germany","institution_ids":["https://openalex.org/I189712700"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032025793","display_name":"Nina Hasiwa","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I189712700","display_name":"University of Konstanz","ror":"https://ror.org/0546hnb39","country_code":"DE","type":"education","lineage":["https://openalex.org/I189712700"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Nina Hasiwa","raw_affiliation_strings":["Doerenkamp-Zbinden Chair for In-vitro Toxicology and Biomedicine and Center for Alternatives to Animal Testing in Europe (CAAT-Europe), University of Konstanz, D-78467 Konstanz, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Doerenkamp-Zbinden Chair for In-vitro Toxicology and Biomedicine and Center for Alternatives to Animal Testing in Europe (CAAT-Europe), University of Konstanz, D-78467 Konstanz, Germany","institution_ids":["https://openalex.org/I189712700"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5086695405","display_name":"Mardas Daneshian","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I189712700","display_name":"University of Konstanz","ror":"https://ror.org/0546hnb39","country_code":"DE","type":"education","lineage":["https://openalex.org/I189712700"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Mardas Daneshian","raw_affiliation_strings":["Doerenkamp-Zbinden Chair for In-vitro Toxicology and Biomedicine and Center for Alternatives to Animal Testing in Europe (CAAT-Europe), University of Konstanz, D-78467 Konstanz, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Doerenkamp-Zbinden Chair for In-vitro Toxicology and Biomedicine and Center for Alternatives to Animal Testing in Europe (CAAT-Europe), University of Konstanz, D-78467 Konstanz, Germany","institution_ids":["https://openalex.org/I189712700"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5091124551","display_name":"Thomas H\u00e4rtung","orcid":"https://orcid.org/0000-0003-1359-7689","observed_orcids":["https://orcid.org/0000-0003-1359-7689"]},"institutions":[{"id":"https://openalex.org/I189712700","display_name":"University of Konstanz","ror":"https://ror.org/0546hnb39","country_code":"DE","type":"education","lineage":["https://openalex.org/I189712700"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Thomas Hartung","raw_affiliation_strings":["Doerenkamp-Zbinden Chair for In-vitro Toxicology and Biomedicine and Center for Alternatives to Animal Testing in Europe (CAAT-Europe), University of Konstanz, D-78467 Konstanz, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Doerenkamp-Zbinden Chair for In-vitro Toxicology and Biomedicine and Center for Alternatives to Animal Testing in Europe (CAAT-Europe), University of Konstanz, D-78467 Konstanz, Germany","institution_ids":["https://openalex.org/I189712700"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5022661690"],"corresponding_institution_ids":["https://openalex.org/I189712700"],"apc_list":{"value":2560,"currency":"USD","value_usd":2560},"apc_paid":null,"fwci":14.9139,"has_fulltext":false,"cited_by_count":100,"citation_normalized_percentile":{"value":0.99616005,"is_in_top_1_percent":true,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":88,"max":100},"biblio":{"volume":"1","issue":"1","first_page":"8","last_page":"22"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12281","display_name":"Animal testing and alternatives","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/3404","display_name":"Small Animals"},"field":{"id":"https://openalex.org/fields/34","display_name":"Veterinary"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T12281","display_name":"Animal testing and alternatives","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/3404","display_name":"Small Animals"},"field":{"id":"https://openalex.org/fields/34","display_name":"Veterinary"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T14072","display_name":"Immunotoxicology and immune responses","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.0,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/alternatives-to-animal-testing","display_name":"alternatives to animal testing","score":0.9599999785423279},{"id":"https://openalex.org/keywords/method-validation","display_name":"method validation","score":0.8109999895095825},{"id":"https://openalex.org/keywords/quality-control","display_name":"quality control","score":0.921999990940094},{"id":"https://openalex.org/keywords/phototoxicity-testing","display_name":"phototoxicity testing","score":0.5860000252723694},{"id":"https://openalex.org/keywords/eye-irritation","display_name":"eye irritation","score":0.8199999928474426},{"id":"https://openalex.org/keywords/pyrogen-test","display_name":"pyrogen testing","score":0.8330000042915344},{"id":"https://openalex.org/keywords/botulinum-toxin","display_name":"botulinum toxin","score":0.8320000171661377},{"id":"https://openalex.org/keywords/regulatory-validation","display_name":"regulatory validation","score":0.3479999899864197},{"id":"https://openalex.org/keywords/model-building","display_name":"model development","score":0.5329999923706055}],"concepts":[{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.6940864324569702},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.6633725166320801},{"id":"https://openalex.org/C2779717098","wikidata":"https://www.wikidata.org/wiki/Q131207","display_name":"Cosmetics","level":2,"score":0.5440165400505066},{"id":"https://openalex.org/C98045186","wikidata":"https://www.wikidata.org/wiki/Q205663","display_name":"Process (computing)","level":2,"score":0.5350108742713928},{"id":"https://openalex.org/C183696295","wikidata":"https://www.wikidata.org/wiki/Q2487696","display_name":"Biochemical engineering","level":1,"score":0.5191706418991089},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.493464857339859},{"id":"https://openalex.org/C2994251472","wikidata":"https://www.wikidata.org/wiki/Q77776","display_name":"Eye irritation","level":3,"score":0.4416029453277588},{"id":"https://openalex.org/C61272859","wikidata":"https://www.wikidata.org/wiki/Q7834031","display_name":"Transferability","level":3,"score":0.4285505414009094},{"id":"https://openalex.org/C200601418","wikidata":"https://www.wikidata.org/wiki/Q2193887","display_name":"Reliability engineering","level":1,"score":0.41006213426589966},{"id":"https://openalex.org/C539667460","wikidata":"https://www.wikidata.org/wiki/Q2414942","display_name":"Management science","level":1,"score":0.3388330340385437},{"id":"https://openalex.org/C201995342","wikidata":"https://www.wikidata.org/wiki/Q682496","display_name":"Systems engineering","level":1,"score":0.3240693211555481},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.2916731834411621},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.22127294540405273},{"id":"https://openalex.org/C2777063393","wikidata":"https://www.wikidata.org/wiki/Q77776","display_name":"Irritation","level":2,"score":0.22035735845565796},{"id":"https://openalex.org/C119857082","wikidata":"https://www.wikidata.org/wiki/Q2539","display_name":"Machine learning","level":1,"score":0.09655466675758362},{"id":"https://openalex.org/C140331021","wikidata":"https://www.wikidata.org/wiki/Q1868104","display_name":"Logit","level":2,"score":0.0},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.0},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.0},{"id":"https://openalex.org/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.0},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0},{"id":"https://openalex.org/C111472728","wikidata":"https://www.wikidata.org/wiki/Q9471","display_name":"Epistemology","level":1,"score":0.0}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.1039/c2tx20011b","doi":"https://doi.org/10.1039/c2tx20011b","is_oa":false,"landing_page_url":"https://doi.org/10.1039/c2tx20011b","pdf_url":null,"source":{"id":"https://openalex.org/S2494971184","display_name":"Toxicology Research","issn_l":"2045-452X","issn":["2045-452X","2045-4538"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-d","ki-jl-1","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Toxicology Research","raw_type":"journal-article"},{"id":"pmh:oai:kops.uni-konstanz.de:123456789/19871","doi":null,"is_oa":false,"landing_page_url":"http://nbn-resolving.de/urn:nbn:de:bsz:352-198717","pdf_url":null,"source":{"id":"https://openalex.org/S4306401487","display_name":"KOPS (University of Konstanz)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I189712700","host_organization_name":"University of Konstanz","host_organization_lineage":["https://openalex.org/I189712700"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Toxicology Research. 2012, 1(1), S. 8-22. ISSN 2045-452X. Verf\u00fcgbar unter: doi: 10.1039/C2TX20011B","raw_type":"doc-type:article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.5683000087738037,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"sustainable_development_goals_aurora":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":164,"referenced_works":["https://openalex.org/W4878504","https://openalex.org/W15532337","https://openalex.org/W28767225","https://openalex.org/W30207173","https://openalex.org/W36504973","https://openalex.org/W58781905","https://openalex.org/W60314632","https://openalex.org/W71776049","https://openalex.org/W72643466","https://openalex.org/W79119690","https://openalex.org/W112461389","https://openalex.org/W156766078","https://openalex.org/W183482919","https://openalex.org/W191903083","https://openalex.org/W196523094","https://openalex.org/W202332968","https://openalex.org/W204701526","https://openalex.org/W212139270","https://openalex.org/W1251710288","https://openalex.org/W1499983431","https://openalex.org/W1588823477","https://openalex.org/W1874308907","https://openalex.org/W1969583812","https://openalex.org/W1977931581","https://openalex.org/W1980043152","https://openalex.org/W1982600877","https://openalex.org/W1988312246","https://openalex.org/W1992889545","https://openalex.org/W2004975226","https://openalex.org/W2006606499","https://openalex.org/W2013201801","https://openalex.org/W2016499588","https://openalex.org/W2018647739","https://openalex.org/W2025202608","https://openalex.org/W2026056454","https://openalex.org/W2028357583","https://openalex.org/W2029829067","https://openalex.org/W2035577548","https://openalex.org/W2038309503","https://openalex.org/W2038477730","https://openalex.org/W2042509838","https://openalex.org/W2048632713","https://openalex.org/W2054939434","https://openalex.org/W2062525669","https://openalex.org/W2064629267","https://openalex.org/W2066449469","https://openalex.org/W2066583600","https://openalex.org/W2067884136","https://openalex.org/W2069288872","https://openalex.org/W2080209696","https://openalex.org/W2089503385","https://openalex.org/W2090322921","https://openalex.org/W2090670039","https://openalex.org/W2091236575","https://openalex.org/W2091455056","https://openalex.org/W2092028991","https://openalex.org/W2092838888","https://openalex.org/W2095510160","https://openalex.org/W2099009726","https://openalex.org/W2101715808","https://openalex.org/W2105035559","https://openalex.org/W2109596139","https://openalex.org/W2110877270","https://openalex.org/W2115488868","https://openalex.org/W2116355749","https://openalex.org/W2118190219","https://openalex.org/W2127676159","https://openalex.org/W2131955973","https://openalex.org/W2136384877","https://openalex.org/W2137281582","https://openalex.org/W2138264882","https://openalex.org/W2144961968","https://openalex.org/W2145025818","https://openalex.org/W2149565435","https://openalex.org/W2155490692","https://openalex.org/W2158365071","https://openalex.org/W2159141432","https://openalex.org/W2160190559","https://openalex.org/W2161866869","https://openalex.org/W2163849189","https://openalex.org/W2169989735","https://openalex.org/W2170173246","https://openalex.org/W2171114546","https://openalex.org/W2171954476","https://openalex.org/W2175108059","https://openalex.org/W2184594356","https://openalex.org/W2264539758","https://openalex.org/W2286291890","https://openalex.org/W2289822442","https://openalex.org/W2312549095","https://openalex.org/W2324721020","https://openalex.org/W2324778740","https://openalex.org/W2332268044","https://openalex.org/W2334927069","https://openalex.org/W2336375127","https://openalex.org/W2398310877","https://openalex.org/W2399071058","https://openalex.org/W2399480166","https://openalex.org/W2400347970","https://openalex.org/W2400667289","https://openalex.org/W2401820610","https://openalex.org/W2410518776","https://openalex.org/W2413055582","https://openalex.org/W2415465709","https://openalex.org/W2416097041","https://openalex.org/W2423814909","https://openalex.org/W2432622367","https://openalex.org/W2443378792","https://openalex.org/W2444020974","https://openalex.org/W2465138648","https://openalex.org/W2468005916","https://openalex.org/W2469817184","https://openalex.org/W2469932415","https://openalex.org/W2552664190","https://openalex.org/W2594038651","https://openalex.org/W2617657773","https://openalex.org/W2798182902","https://openalex.org/W2800795607","https://openalex.org/W2802820871","https://openalex.org/W2936888746","https://openalex.org/W4205430247","https://openalex.org/W4205802195","https://openalex.org/W4206294426","https://openalex.org/W4211194195","https://openalex.org/W4212829066","https://openalex.org/W4212888571","https://openalex.org/W4213218273","https://openalex.org/W4229712505","https://openalex.org/W4232351105","https://openalex.org/W4232405518","https://openalex.org/W4233425629","https://openalex.org/W4233625704","https://openalex.org/W4236212665","https://openalex.org/W4238610611","https://openalex.org/W4240204571","https://openalex.org/W4243361639","https://openalex.org/W4244102216","https://openalex.org/W4244566158","https://openalex.org/W4245146425","https://openalex.org/W4246145996","https://openalex.org/W4246570196","https://openalex.org/W4247390740","https://openalex.org/W4247972695","https://openalex.org/W4252420919","https://openalex.org/W4252693454","https://openalex.org/W4253655306","https://openalex.org/W4254784090","https://openalex.org/W4255381023","https://openalex.org/W4298066452","https://openalex.org/W4299955996","https://openalex.org/W6600201948","https://openalex.org/W6601140464","https://openalex.org/W6602389366","https://openalex.org/W6608242429","https://openalex.org/W6677348298","https://openalex.org/W6683487379","https://openalex.org/W6702315339","https://openalex.org/W6716391434","https://openalex.org/W6718489453","https://openalex.org/W6729695028","https://openalex.org/W6734610000","https://openalex.org/W6750542741","https://openalex.org/W6750585432","https://openalex.org/W6751525827"],"related_works":["https://openalex.org/W2349581650","https://openalex.org/W2392502762","https://openalex.org/W2349871865","https://openalex.org/W2350822613","https://openalex.org/W2338145888","https://openalex.org/W2383889191","https://openalex.org/W2379729224","https://openalex.org/W3110071814","https://openalex.org/W2317497837","https://openalex.org/W4239525440"],"abstract_inverted_index":{"Abstract":[0],"Alternatives":[1],"to":[2,82,107],"animal":[3],"testing":[4],"have":[5,104,158],"been":[6,105],"developed":[7],"mainly":[8],"in":[9,40,119],"the":[10,20,45,48,57,60,72,89,128,142],"fields":[11],"of":[12,22,29,47,50,59,63,77,92,122,130,144,164],"toxicology":[13],"and":[14,31,75,100,134,147,162,169,172],"vaccine":[15],"testing.":[16],"Typical":[17],"examples":[18,35],"are":[19,136,167,174],"evaluation":[21,129],"phototoxicity,":[23],"eye":[24],"irritation":[25],"or":[26,55,110],"skin":[27],"corrosion/irritation":[28],"cosmetics":[30],"industrial":[32],"chemicals.":[33],"However,":[34],"can":[36],"also":[37,151],"be":[38,83],"found":[39],"other":[41],"biomedical":[42],"areas,":[43],"such":[44,65],"control":[46,58],"quality":[49,135,148],"drug":[51],"preparations":[52],"for":[53,56,127],"pyrogens":[54],"production":[61],"process":[62],"biologics,":[64],"as":[66],"botulinum":[67],"neurotoxin.":[68],"For":[69],"regulatory":[70],"purposes,":[71],"quality,":[73],"transferability":[74],"predictivity":[76],"an":[78,153],"alternative":[79],"method":[80,123],"needs":[81],"evaluated.":[84],"This":[85],"procedure":[86],"is":[87],"called":[88],"\u201cvalidation":[90],"process\u201d":[91],"a":[93,120,131],"new":[94,170],"method.":[95],"It":[96],"follows":[97],"defined":[98],"rules,":[99],"several":[101],"governmental":[102],"institutions":[103],"established":[106],"perform,":[108],"supervise":[109],"advise":[111],"on":[112,155],"this":[113,116],"process.":[114],"As":[115],"often":[117],"results":[118],"delay":[121],"implementation,":[124],"different":[125],"alternatives":[126],"method's":[132],"suitability":[133],"under":[137],"discussion.":[138],"We":[139,150],"describe":[140],"here":[141],"principles":[143],"model":[145],"development":[146],"control.":[149],"give":[152],"overview":[154],"methods":[156],"that":[157],"undergone":[159],"validation.":[160],"Strengths":[161],"shortcomings":[163],"traditional":[165],"approaches":[166],"discussed,":[168],"developments":[171],"challenges":[173],"outlined.":[175]},"counts_by_year":[{"year":2026,"cited_by_count":6},{"year":2025,"cited_by_count":2},{"year":2024,"cited_by_count":10},{"year":2023,"cited_by_count":6},{"year":2022,"cited_by_count":4},{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":3},{"year":2019,"cited_by_count":8},{"year":2018,"cited_by_count":12},{"year":2017,"cited_by_count":6},{"year":2016,"cited_by_count":7},{"year":2015,"cited_by_count":6},{"year":2014,"cited_by_count":14},{"year":2013,"cited_by_count":10},{"year":2012,"cited_by_count":5}],"updated_date":"2026-10-14T16:39:01.820549","created_date":"2025-10-10T00:00:00"}