{"id":"https://openalex.org/W2584499400","doi":"https://doi.org/10.1080/17425255.2017.1290082","title":"Human biology-based drug safety evaluation: scientific rationale, current status and future challenges","display_name":"Human biology-based drug safety evaluation: scientific rationale, current status and future challenges","publication_year":2017,"publication_date":"2017-02-02","ids":{"openalex":"https://openalex.org/W2584499400","doi":"https://doi.org/10.1080/17425255.2017.1290082","mag":"2584499400","pmid":"https://pubmed.ncbi.nlm.nih.gov/28150517"},"language":"en","primary_location":{"id":"doi:10.1080/17425255.2017.1290082","doi":"https://doi.org/10.1080/17425255.2017.1290082","is_oa":false,"landing_page_url":"https://doi.org/10.1080/17425255.2017.1290082","pdf_url":null,"source":{"id":"https://openalex.org/S102336391","display_name":"Expert Opinion on Drug Metabolism & Toxicology","issn_l":"1742-5255","issn":["1742-5255","1744-7607"],"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","vabb-shw"],"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":"Expert Opinion on Drug Metabolism &amp; Toxicology","raw_type":"journal-article"},"volume":null,"type":"review","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/A5028281331","display_name":"J. Gerry Kenna","orcid":"https://orcid.org/0000-0002-6927-8962","observed_orcids":["https://orcid.org/0000-0002-6927-8962"]},"institutions":[{"id":"https://openalex.org/I4210115816","display_name":"Safer Medicines Trust","ror":"https://ror.org/029v85503","country_code":"GB","type":"nonprofit","lineage":["https://openalex.org/I4210115816"]}],"countries":["GB"],"is_corresponding":true,"raw_author_name":"J. Gerry Kenna","raw_affiliation_strings":["Safer Medicines Trust, Macclesfield, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Safer Medicines Trust, Macclesfield, UK","institution_ids":["https://openalex.org/I4210115816"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5028281331"],"corresponding_institution_ids":["https://openalex.org/I4210115816"],"apc_list":null,"apc_paid":null,"fwci":0.1761,"has_fulltext":false,"cited_by_count":7,"citation_normalized_percentile":{"value":0.11519608,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":96},"biblio":{"volume":"13","issue":"5","first_page":"567","last_page":"574"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11465","display_name":"Drug-Induced Hepatotoxicity and Protection","score":0.7562999725341797,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T11465","display_name":"Drug-Induced Hepatotoxicity and Protection","score":0.7562999725341797,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T12281","display_name":"Animal testing and alternatives","score":0.16200000047683716,"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/T11117","display_name":"Drug-Induced Adverse Reactions","score":0.029100000858306885,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology (medical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/idiosyncratic-adverse-drug-reactions","display_name":"idiosyncratic drug reactions","score":0.9769999980926514},{"id":"https://openalex.org/keywords/drug-safety-assessment","display_name":"drug safety assessment","score":0.781000018119812},{"id":"https://openalex.org/keywords/drug-induced-liver-injury","display_name":"drug-induced liver injury","score":0.8619999885559082},{"id":"https://openalex.org/keywords/cardiotoxicity","display_name":"cardiotoxicity","score":0.9340000152587891},{"id":"https://openalex.org/keywords/in-vitro-toxicity-testing","display_name":"in vitro toxicity testing","score":0.9290000200271606},{"id":"https://openalex.org/keywords/in-vitro-in-vivo-correlation","display_name":"in vitro-in vivo correlation","score":0.5920000076293945},{"id":"https://openalex.org/keywords/animal-toxicity-studies","display_name":"animal toxicity studies","score":0.6589999794960022}],"concepts":[{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.4460398852825165},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.4433930516242981},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4072189927101135},{"id":"https://openalex.org/C70721500","wikidata":"https://www.wikidata.org/wiki/Q177005","display_name":"Computational biology","level":1,"score":0.3510744571685791},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.34850871562957764},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.24683693051338196}],"mesh":[{"descriptor_ui":"D000818","descriptor_name":"Animals","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":"D013045","descriptor_name":"Species Specificity","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015195","descriptor_name":"Drug Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D018675","descriptor_name":"Toxicity Tests","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D023381","descriptor_name":"Endpoint Determination","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D056486","descriptor_name":"Chemical and Drug Induced Liver Injury","qualifier_ui":"Q000175","qualifier_name":"diagnosis","is_major_topic":false},{"descriptor_ui":"D056486","descriptor_name":"Chemical and Drug Induced Liver Injury","qualifier_ui":"Q000209","qualifier_name":"etiology","is_major_topic":false},{"descriptor_ui":"D056486","descriptor_name":"Chemical and Drug Induced Liver Injury","qualifier_ui":"Q000453","qualifier_name":"epidemiology","is_major_topic":false},{"descriptor_ui":"D064420","descriptor_name":"Drug-Related Side Effects and Adverse Reactions","qualifier_ui":"Q000175","qualifier_name":"diagnosis","is_major_topic":true},{"descriptor_ui":"D064420","descriptor_name":"Drug-Related Side Effects and Adverse Reactions","qualifier_ui":"Q000209","qualifier_name":"etiology","is_major_topic":false},{"descriptor_ui":"D064420","descriptor_name":"Drug-Related Side Effects and Adverse Reactions","qualifier_ui":"Q000453","qualifier_name":"epidemiology","is_major_topic":false},{"descriptor_ui":"D066126","descriptor_name":"Cardiotoxicity","qualifier_ui":"Q000175","qualifier_name":"diagnosis","is_major_topic":false},{"descriptor_ui":"D066126","descriptor_name":"Cardiotoxicity","qualifier_ui":"Q000209","qualifier_name":"etiology","is_major_topic":false},{"descriptor_ui":"D066126","descriptor_name":"Cardiotoxicity","qualifier_ui":"Q000453","qualifier_name":"epidemiology","is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1080/17425255.2017.1290082","doi":"https://doi.org/10.1080/17425255.2017.1290082","is_oa":false,"landing_page_url":"https://doi.org/10.1080/17425255.2017.1290082","pdf_url":null,"source":{"id":"https://openalex.org/S102336391","display_name":"Expert Opinion on Drug Metabolism & Toxicology","issn_l":"1742-5255","issn":["1742-5255","1744-7607"],"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","vabb-shw"],"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":"Expert Opinion on Drug Metabolism &amp; Toxicology","raw_type":"journal-article"},{"id":"pmid:28150517","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/28150517","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":"Expert opinion on drug metabolism & toxicology","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.9537000060081482,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":67,"referenced_works":["https://openalex.org/W1527821398","https://openalex.org/W1546635604","https://openalex.org/W1550119222","https://openalex.org/W1560686237","https://openalex.org/W1575741575","https://openalex.org/W1609658954","https://openalex.org/W1614484620","https://openalex.org/W1663154925","https://openalex.org/W1797606584","https://openalex.org/W1895993106","https://openalex.org/W1903040240","https://openalex.org/W1917479864","https://openalex.org/W1928147381","https://openalex.org/W1955830815","https://openalex.org/W1967105697","https://openalex.org/W1969879564","https://openalex.org/W1971967721","https://openalex.org/W1977122152","https://openalex.org/W1977229794","https://openalex.org/W1983576933","https://openalex.org/W1992746042","https://openalex.org/W1992890364","https://openalex.org/W1995042037","https://openalex.org/W1996601943","https://openalex.org/W1996935441","https://openalex.org/W1998101020","https://openalex.org/W2009891171","https://openalex.org/W2017194393","https://openalex.org/W2017783406","https://openalex.org/W2022868257","https://openalex.org/W2023922443","https://openalex.org/W2027595591","https://openalex.org/W2028992331","https://openalex.org/W2029818729","https://openalex.org/W2030890271","https://openalex.org/W2034203319","https://openalex.org/W2037001869","https://openalex.org/W2038522726","https://openalex.org/W2049789320","https://openalex.org/W2053891616","https://openalex.org/W2055044285","https://openalex.org/W2088410521","https://openalex.org/W2098159917","https://openalex.org/W2098472712","https://openalex.org/W2098952554","https://openalex.org/W2104209550","https://openalex.org/W2117502107","https://openalex.org/W2124507637","https://openalex.org/W2127284788","https://openalex.org/W2133714677","https://openalex.org/W2133744444","https://openalex.org/W2134837921","https://openalex.org/W2135117972","https://openalex.org/W2145137957","https://openalex.org/W2145394548","https://openalex.org/W2146718361","https://openalex.org/W2147489083","https://openalex.org/W2152548885","https://openalex.org/W2153349282","https://openalex.org/W2166520793","https://openalex.org/W2168871876","https://openalex.org/W2171636541","https://openalex.org/W2321490321","https://openalex.org/W2321993463","https://openalex.org/W2327070670","https://openalex.org/W4236808222","https://openalex.org/W4247050267"],"related_works":["https://openalex.org/W2023922443","https://openalex.org/W2898580567","https://openalex.org/W1595407654","https://openalex.org/W2029818729","https://openalex.org/W3004958927","https://openalex.org/W2087495628","https://openalex.org/W2051450679","https://openalex.org/W2039219279","https://openalex.org/W2047250808","https://openalex.org/W2404362650"],"abstract_inverted_index":{"INTRODUCTION:":[0],"Animal":[1],"toxicity":[2,83,141],"studies":[3],"used":[4],"to":[5,14,23,68,85],"assess":[6,24],"the":[7,25,35,180],"safety":[8],"of":[9,27,38,62,116,138,145,160,173,182],"new":[10],"candidate":[11],"pharmaceuticals":[12],"prior":[13],"their":[15],"progression":[16],"into":[17],"human":[18,161,186],"clinical":[19],"trials":[20],"are":[21,40,57,75,132],"unable":[22],"risk":[26,188],"non-pharmacologically":[28],"mediated":[29],"idiosyncratic":[30,117,185],"adverse":[31],"drug":[32,165],"reactions":[33],"(ADRs),":[34],"most":[36],"frequent":[37],"which":[39,81,123,150],"drug-induced":[41],"liver":[42],"injury":[43],"and":[44,51,65,155,163,171,189],"cardiotoxicity.":[45],"Idiosyncratic":[46,73],"ADRs":[47,74],"occur":[48],"only":[49,90],"infrequently":[50],"in":[52,91,101,128,139,167,192,194],"certain":[53,92],"susceptible":[54],"humans,":[55],"but":[56],"caused":[58],"by":[59,77,179],"many":[60],"hundreds":[61],"different":[63,153],"drugs":[64,109],"may":[66],"lead":[67],"serious":[69],"illness.":[70],"Areas":[71],"covered:":[72],"initiated":[76],"drug-related":[78],"chemical":[79,95],"insults,":[80],"cause":[82,111],"due":[84],"susceptibility":[86],"factors":[87],"that":[88,110],"manifest":[89],"patients.":[93],"The":[94],"insults":[96],"can":[97],"be":[98],"detected":[99],"using":[100],"vitro":[102,140],"assays.":[103],"These":[104],"enable":[105],"useful":[106],"discrimination":[107],"between":[108,184],"high":[112],"versus":[113],"low":[114],"levels":[115],"ADR":[118,187],"concern.":[119],"Especially":[120],"promising":[121],"assays,":[122,149],"have":[124],"been":[125,177],"described":[126],"recently":[127],"peer-reviewed":[129],"scientific":[130],"literature,":[131],"highlighted.":[133],"Expert":[134],"opinion:":[135],"Effective":[136],"interpretation":[137],"data":[142],"requires":[143],"integration":[144],"endpoints":[146],"from":[147],"multiple":[148],"each":[151],"address":[152],"mechanisms,":[154],"must":[156],"also":[157],"take":[158],"account":[159],"systemic":[162],"tissue":[164],"exposure":[166],"vivo.":[168],"Widespread":[169],"acceptance":[170],"use":[172],"such":[174],"assays":[175],"has":[176],"hampered":[178],"lack":[181],"correlation":[183],"toxicities":[190],"observed":[191],"vivo":[193],"animals.":[195]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2022,"cited_by_count":2},{"year":2019,"cited_by_count":2},{"year":2018,"cited_by_count":2}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2017-02-10T00:00:00"}
