{"id":"https://openalex.org/W2344371104","doi":"https://doi.org/10.3109/10408444.2016.1163664","title":"Critical analysis of carcinogenicity study outcomes. Relationship with pharmacological properties","display_name":"Critical analysis of carcinogenicity study outcomes. Relationship with pharmacological properties","publication_year":2016,"publication_date":"2016-04-26","ids":{"openalex":"https://openalex.org/W2344371104","doi":"https://doi.org/10.3109/10408444.2016.1163664","mag":"2344371104","pmid":"https://pubmed.ncbi.nlm.nih.gov/27116466"},"language":"en","primary_location":{"id":"doi:10.3109/10408444.2016.1163664","doi":"https://doi.org/10.3109/10408444.2016.1163664","is_oa":false,"landing_page_url":"https://doi.org/10.3109/10408444.2016.1163664","pdf_url":null,"source":{"id":"https://openalex.org/S78069630","display_name":"Critical Reviews in Toxicology","issn_l":"0045-6446","issn":["0045-6446","1040-8444","1547-6898"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1"],"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Critical Reviews in Toxicology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"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/A5090019138","display_name":"Jan Willem van der Laan","orcid":"https://orcid.org/0000-0003-2963-6136","observed_orcids":["https://orcid.org/0000-0003-2963-6136"]},"institutions":[{"id":"https://openalex.org/I4210150351","display_name":"Medicines Evaluation Board","ror":"https://ror.org/05mv4rb84","country_code":"NL","type":"education","lineage":["https://openalex.org/I4210150351"]}],"countries":["NL"],"is_corresponding":true,"raw_author_name":"Jan Willem van der Laan","raw_affiliation_strings":["Medicines Evaluation Board, Utrecht, The Netherlands;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Medicines Evaluation Board, Utrecht, The Netherlands;","institution_ids":["https://openalex.org/I4210150351"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5108654924","display_name":"Peter Kasper","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I123859907","display_name":"Federal Institute for Drugs and Medical Devices","ror":"https://ror.org/05ex5vz81","country_code":"DE","type":"funder","lineage":["https://openalex.org/I123859907"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Peter Kasper","raw_affiliation_strings":["Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany;","institution_ids":["https://openalex.org/I123859907"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5049357095","display_name":"Beatriz Silva Lima","orcid":"https://orcid.org/0000-0003-0910-7245","observed_orcids":["https://orcid.org/0000-0003-0910-7245"]},"institutions":[{"id":"https://openalex.org/I141596103","display_name":"University of Lisbon","ror":"https://ror.org/01c27hj86","country_code":"PT","type":"education","lineage":["https://openalex.org/I141596103"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"Beatriz Silva Lima","raw_affiliation_strings":["Faculty of Pharmacy, Universidade De Lisboa, Lisbon, Portugal;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Faculty of Pharmacy, Universidade De Lisboa, Lisbon, Portugal;","institution_ids":["https://openalex.org/I141596103"]}]},{"author_position":"middle","author":{"id":null,"display_name":"David R. Jones","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405282191","display_name":"Medicines and Healthcare products Regulatory Agency","ror":"https://ror.org/05fan1e59","country_code":"GB","type":"government","lineage":["https://openalex.org/I4405282191"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"David R. Jones","raw_affiliation_strings":["Medicines and Healthcare Products Regulatory Agency, London, UK;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Medicines and Healthcare Products Regulatory Agency, London, UK;","institution_ids":["https://openalex.org/I4405282191"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5089567201","display_name":"Markku Pasanen","orcid":"https://orcid.org/0000-0002-2557-9034","observed_orcids":["https://orcid.org/0000-0002-2557-9034"]},"institutions":[{"id":"https://openalex.org/I175532246","display_name":"University of Eastern Finland","ror":"https://ror.org/00cyydd11","country_code":"FI","type":"education","lineage":["https://openalex.org/I175532246"]}],"countries":["FI"],"is_corresponding":false,"raw_author_name":"Markku Pasanen","raw_affiliation_strings":["Faculty of Health Sciences, School of Pharmacy, University of Eastern Finland, Kuopio, Finland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Faculty of Health Sciences, School of Pharmacy, University of Eastern Finland, Kuopio, Finland","institution_ids":["https://openalex.org/I175532246"]}]}],"institutions":[],"countries_distinct_count":5,"institutions_distinct_count":5,"corresponding_author_ids":["https://openalex.org/A5090019138"],"corresponding_institution_ids":["https://openalex.org/I4210150351"],"apc_list":null,"apc_paid":null,"fwci":2.0231,"has_fulltext":false,"cited_by_count":42,"citation_normalized_percentile":{"value":0.84658222,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":90,"max":98},"biblio":{"volume":"46","issue":"7","first_page":"587","last_page":"614"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10433","display_name":"Carcinogens and Genotoxicity Assessment","score":0.9458000063896179,"subfield":{"id":"https://openalex.org/subfields/1306","display_name":"Cancer Research"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T10433","display_name":"Carcinogens and Genotoxicity Assessment","score":0.9458000063896179,"subfield":{"id":"https://openalex.org/subfields/1306","display_name":"Cancer Research"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T12281","display_name":"Animal testing and alternatives","score":0.0284000001847744,"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":0.013799999840557575,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/carcinogenicity","display_name":"carcinogenicity","score":0.6940000057220459},{"id":"https://openalex.org/keywords/chronic-toxicity","display_name":"chronic toxicity","score":0.8420000076293945},{"id":"https://openalex.org/keywords/pharmacological-properties","display_name":"pharmacological properties","score":0.7839999794960022},{"id":"https://openalex.org/keywords/pharmacological-classes","display_name":"pharmacological classes","score":0.6539999842643738},{"id":"https://openalex.org/keywords/histopathology","display_name":"histopathology","score":0.9549999833106995},{"id":"https://openalex.org/keywords/pharmaceuticals","display_name":"pharmaceuticals","score":0.5659999847412109},{"id":"https://openalex.org/keywords/regulatory-waivers","display_name":"regulatory waivers","score":0.6759999990463257},{"id":"https://openalex.org/keywords/reduction-of-animal-use","display_name":"animal use reduction","score":0.4880000054836273},{"id":"https://openalex.org/keywords/risk-assessment","display_name":"risk assessment","score":0.3779999911785126},{"id":"https://openalex.org/keywords/therapeutic-target","display_name":"therapeutic target","score":0.6069999933242798}],"concepts":[{"id":"https://openalex.org/C114246631","wikidata":"https://www.wikidata.org/wiki/Q187661","display_name":"Carcinogen","level":2,"score":0.7181843519210815},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.5182157158851624},{"id":"https://openalex.org/C121587506","wikidata":"https://www.wikidata.org/wiki/Q6888113","display_name":"Mode of action","level":2,"score":0.44399943947792053},{"id":"https://openalex.org/C33070731","wikidata":"https://www.wikidata.org/wiki/Q7218","display_name":"Toxicology","level":1,"score":0.4410397708415985},{"id":"https://openalex.org/C29730261","wikidata":"https://www.wikidata.org/wiki/Q274160","display_name":"Toxicity","level":2,"score":0.42572787404060364},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.420979380607605},{"id":"https://openalex.org/C60644358","wikidata":"https://www.wikidata.org/wiki/Q128570","display_name":"Bioinformatics","level":1,"score":0.3686387240886688},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.20869502425193787},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.1766200065612793},{"id":"https://openalex.org/C54355233","wikidata":"https://www.wikidata.org/wiki/Q7162","display_name":"Genetics","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000069437","descriptor_name":"Pharmacological Phenomena","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000818","descriptor_name":"Animals","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002273","descriptor_name":"Carcinogens","qualifier_ui":"Q000633","qualifier_name":"toxicity","is_major_topic":true},{"descriptor_ui":"D004364","descriptor_name":"Pharmaceutical Preparations","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015197","descriptor_name":"Carcinogenicity Tests","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D051381","descriptor_name":"Rats","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.3109/10408444.2016.1163664","doi":"https://doi.org/10.3109/10408444.2016.1163664","is_oa":false,"landing_page_url":"https://doi.org/10.3109/10408444.2016.1163664","pdf_url":null,"source":{"id":"https://openalex.org/S78069630","display_name":"Critical Reviews in Toxicology","issn_l":"0045-6446","issn":["0045-6446","1040-8444","1547-6898"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1"],"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Critical Reviews in Toxicology","raw_type":"journal-article"},{"id":"pmid:27116466","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/27116466","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Critical reviews in toxicology","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.9537000060081482,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":115,"referenced_works":["https://openalex.org/W55808841","https://openalex.org/W67943056","https://openalex.org/W187906137","https://openalex.org/W1000149840","https://openalex.org/W1033623824","https://openalex.org/W1484318667","https://openalex.org/W1490529261","https://openalex.org/W1512266598","https://openalex.org/W1575384040","https://openalex.org/W1755903692","https://openalex.org/W1781196127","https://openalex.org/W1798063743","https://openalex.org/W1870623700","https://openalex.org/W1920604003","https://openalex.org/W1965555285","https://openalex.org/W1968173346","https://openalex.org/W1969144409","https://openalex.org/W1970446344","https://openalex.org/W1970778758","https://openalex.org/W1971395338","https://openalex.org/W1973199147","https://openalex.org/W1975844011","https://openalex.org/W1977367946","https://openalex.org/W1979192995","https://openalex.org/W1979257183","https://openalex.org/W1980394423","https://openalex.org/W1981766817","https://openalex.org/W1982410021","https://openalex.org/W1982792038","https://openalex.org/W1984048248","https://openalex.org/W1985101172","https://openalex.org/W1989931702","https://openalex.org/W1993655183","https://openalex.org/W1996103084","https://openalex.org/W1997382330","https://openalex.org/W2001192060","https://openalex.org/W2006298776","https://openalex.org/W2015367379","https://openalex.org/W2018281081","https://openalex.org/W2022018558","https://openalex.org/W2024824028","https://openalex.org/W2029490819","https://openalex.org/W2030159395","https://openalex.org/W2032812294","https://openalex.org/W2033800905","https://openalex.org/W2034577495","https://openalex.org/W2034706025","https://openalex.org/W2035441617","https://openalex.org/W2040430700","https://openalex.org/W2041866608","https://openalex.org/W2046880179","https://openalex.org/W2049173605","https://openalex.org/W2049627106","https://openalex.org/W2052028397","https://openalex.org/W2055451075","https://openalex.org/W2056385648","https://openalex.org/W2056852922","https://openalex.org/W2057314663","https://openalex.org/W2063604427","https://openalex.org/W2066583605","https://openalex.org/W2068651326","https://openalex.org/W2069723602","https://openalex.org/W2070773715","https://openalex.org/W2072689861","https://openalex.org/W2072723883","https://openalex.org/W2076244798","https://openalex.org/W2079445758","https://openalex.org/W2086770774","https://openalex.org/W2088428578","https://openalex.org/W2088727314","https://openalex.org/W2096566836","https://openalex.org/W2097170334","https://openalex.org/W2098091211","https://openalex.org/W2098646490","https://openalex.org/W2098952008","https://openalex.org/W2112235272","https://openalex.org/W2113215046","https://openalex.org/W2114425498","https://openalex.org/W2115097854","https://openalex.org/W2116746992","https://openalex.org/W2118648354","https://openalex.org/W2119399704","https://openalex.org/W2122725894","https://openalex.org/W2124439248","https://openalex.org/W2127711934","https://openalex.org/W2130407651","https://openalex.org/W2132056377","https://openalex.org/W2137146393","https://openalex.org/W2138512826","https://openalex.org/W2139341329","https://openalex.org/W2143114558","https://openalex.org/W2143824068","https://openalex.org/W2146165316","https://openalex.org/W2146433687","https://openalex.org/W2148810822","https://openalex.org/W2150985748","https://openalex.org/W2154921342","https://openalex.org/W2161205915","https://openalex.org/W2164116576","https://openalex.org/W2164355098","https://openalex.org/W2164467062","https://openalex.org/W2164514663","https://openalex.org/W2168779696","https://openalex.org/W2169520297","https://openalex.org/W2169896830","https://openalex.org/W2188623669","https://openalex.org/W2202626070","https://openalex.org/W2223903658","https://openalex.org/W2343341732","https://openalex.org/W2405887519","https://openalex.org/W2409922832","https://openalex.org/W2416591729","https://openalex.org/W2725232769","https://openalex.org/W2950544797","https://openalex.org/W4233639050"],"related_works":["https://openalex.org/W2148810822","https://openalex.org/W2531087303","https://openalex.org/W4394722965","https://openalex.org/W2137842271","https://openalex.org/W2096566836","https://openalex.org/W2620756052","https://openalex.org/W2593430561","https://openalex.org/W3192057998","https://openalex.org/W2162674079","https://openalex.org/W2438826745"],"abstract_inverted_index":{"Predicting":[0],"the":[1,26,38,74,77,87,116,119,145,149,167,176,196,203,207,222,256,272,282,290],"outcome":[2,75,161],"of":[3,28,41,47,76,90,92,111,118,121,139,166,178,184,190,199,224,227,258,297],"life-time":[4],"carcinogenicity":[5,64,160,186,226,241,264],"studies":[6,14,30,242],"in":[7,15,20,44,66,73,152,211,213,266,271,294],"rats":[8,153],"based":[9,114],"on":[10,37,97,115,285],"chronic":[11,208],"(6-month)":[12],"toxicity":[13,209],"this":[16,54,191],"species":[17],"is":[18,71,130,193],"possible":[19],"some":[21,93],"instances.":[22],"This":[23,229],"should":[24,55,174],"reduce":[25],"number":[27,40,296],"such":[29,250],"and":[31,126,148,171],"hence":[32],"have":[33,107,254],"a":[34,51,60,63,82,98,112,133,259,263,295],"significant":[35],"impact":[36],"total":[39],"animals":[42],"used":[43],"safety":[45],"assessment":[46],"new":[48],"medicines.":[49],"From":[50],"regulatory":[52,127,260],"perspective,":[53],"be":[56],"sufficient":[57],"to":[58,159,194,215,220,234,249],"grant":[59],"waiver":[61,261],"for":[62,86,262,275],"study":[65,210,265],"those":[67],"cases":[68],"where":[69],"there":[70],"confidence":[72],"prediction.":[78],"Pharmacological":[79],"properties":[80,198],"are":[81],"frequent":[83],"key":[84],"factor":[85],"carcinogenic":[88],"mode":[89],"action":[91],"pharmaceuticals,":[94],"but":[95],"data-analysis":[96],"large":[99],"dataset":[100,113],"has":[101],"never":[102],"been":[103],"formally":[104],"conducted.":[105],"We":[106,253],"conducted":[108],"an":[109,140,217,251],"analysis":[110,192],"perspective":[117],"pharmacology":[120,173],"255":[122],"compounds":[123,200],"from":[124,206],"industrial":[125],"sources.":[128],"It":[129],"proposed":[131,291],"that":[132],"pharmacological,":[134],"class-specific,":[135],"model":[136],"may":[137],"consist":[138],"overall":[141],"causal":[142],"relationship":[143],"between":[144],"pharmacological":[146,197],"class":[147],"histopathology":[150,204],"findings":[151,205],"after":[154,162],"6":[155],"months":[156],"treatment,":[157],"leading":[158],"2":[163],"years.":[164],"Knowledge":[165],"intended":[168],"drug":[169],"target":[170],"pathway":[172],"enhance":[175],"prediction":[177,292],"either":[179],"positive":[180],"or":[181,244],"negative":[182],"outcomes":[183],"rat":[185,240],"studies.":[187,299],"The":[188],"goal":[189],"review":[195],"together":[201],"with":[202],"rodents":[212],"order":[214],"introduce":[216],"integrated":[218],"approach":[219,230,293],"estimate":[221],"risk":[223],"human":[225],"pharmaceuticals.":[228],"would":[231],"allow":[232],"scientists":[233],"define":[235],"conditions":[236],"under":[237],"which":[238],"2-year":[239],"will":[243,245],"not":[246],"add":[247],"value":[248],"assessment.":[252],"demonstrated":[255],"possibility":[257],"rats,":[267],"as":[268,281],"currently":[269],"discussed":[270],"International":[273,283],"Council":[274],"Harmonization":[276,286],"(ICH)":[277],"-":[278],"formerly":[279],"known":[280],"Conference":[284],"(ICH),":[287],"by":[288],"applying":[289],"case":[298]},"counts_by_year":[{"year":2026,"cited_by_count":2},{"year":2025,"cited_by_count":1},{"year":2024,"cited_by_count":6},{"year":2023,"cited_by_count":3},{"year":2022,"cited_by_count":5},{"year":2021,"cited_by_count":5},{"year":2020,"cited_by_count":3},{"year":2019,"cited_by_count":4},{"year":2018,"cited_by_count":5},{"year":2017,"cited_by_count":5},{"year":2016,"cited_by_count":3}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2016-06-24T00:00:00"}
