{"id":"https://openalex.org/W2072267647","doi":"https://doi.org/10.1111/ctr.12305","title":"Long\u2010term evaluation of analytical methods used in sirolimus therapeutic drug monitoring","display_name":"Long\u2010term evaluation of analytical methods used in sirolimus therapeutic drug monitoring","publication_year":2014,"publication_date":"2014-01-30","ids":{"openalex":"https://openalex.org/W2072267647","doi":"https://doi.org/10.1111/ctr.12305","mag":"2072267647","pmid":"https://pubmed.ncbi.nlm.nih.gov/24476346"},"language":"en","primary_location":{"id":"doi:10.1111/ctr.12305","doi":"https://doi.org/10.1111/ctr.12305","is_oa":false,"landing_page_url":"https://doi.org/10.1111/ctr.12305","pdf_url":null,"source":{"id":"https://openalex.org/S4210215907","display_name":"Clinical Transplantation","issn_l":"0902-0063","issn":["0902-0063","1399-0012"],"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-70","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Transplantation","raw_type":"journal-article"},"volume":null,"type":"article","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/A5108422231","display_name":"David W. Holt","orcid":"https://orcid.org/0000-0002-6258-5716","observed_orcids":["https://orcid.org/0000-0002-6258-5716"]},"institutions":[{"id":"https://openalex.org/I165862685","display_name":"St George's, University of London","ror":"https://ror.org/040f08y74","country_code":"GB","type":"education","lineage":["https://openalex.org/I124357947","https://openalex.org/I165862685","https://openalex.org/I4401726869"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"David W. Holt","raw_affiliation_strings":["Analytical Services International St. George's, University of London London UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Analytical Services International St. George's, University of London London UK","institution_ids":["https://openalex.org/I165862685"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5025694734","display_name":"Didier A. Mandelbrot","orcid":"https://orcid.org/0000-0003-3326-8583","observed_orcids":["https://orcid.org/0000-0003-3326-8583"]},"institutions":[{"id":"https://openalex.org/I1316535847","display_name":"Beth Israel Deaconess Medical Center","ror":"https://ror.org/04drvxt59","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1316535847"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Didier A. Mandelbrot","raw_affiliation_strings":["The Transplant Institute; Beth Israel Deaconess Medical Center; Boston MA USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"The Transplant Institute; Beth Israel Deaconess Medical Center; Boston MA USA","institution_ids":["https://openalex.org/I1316535847"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5013142762","display_name":"Michael A. Tortorici","orcid":"https://orcid.org/0000-0002-2822-5805","observed_orcids":["https://orcid.org/0000-0002-2822-5805"]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Michael A. Tortorici","raw_affiliation_strings":["Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5050194925","display_name":"Joan M Korth-Bradley","orcid":"https://orcid.org/0000-0003-2436-9833","observed_orcids":["https://orcid.org/0000-0003-2436-9833"]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Joan M. Korth\u2010Bradley","raw_affiliation_strings":["Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5044300803","display_name":"Debra Sierka","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Debra Sierka","raw_affiliation_strings":["Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5113876254","display_name":"David L\u00e9vy","orcid":"https://orcid.org/0000-0003-0603-0297","observed_orcids":["https://orcid.org/0000-0003-0603-0297"]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Daniel I. Levy","raw_affiliation_strings":["Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5022398010","display_name":"Sandi See Tai","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Sandi See Tai","raw_affiliation_strings":["Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Specialty Care Business Unit, Pfizer Inc, Collegeville, PA, USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5111904978","display_name":"Gary L. Horowitz","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1316535847","display_name":"Beth Israel Deaconess Medical Center","ror":"https://ror.org/04drvxt59","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1316535847"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Gary L. Horowitz","raw_affiliation_strings":["Department of Pathology Beth Israel Deaconess Medical Center Boston MA USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pathology Beth Israel Deaconess Medical Center Boston MA USA","institution_ids":["https://openalex.org/I1316535847"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5111904978"],"corresponding_institution_ids":["https://openalex.org/I1316535847"],"apc_list":{"value":4550,"currency":"USD","value_usd":4550},"apc_paid":null,"fwci":1.7727,"has_fulltext":false,"cited_by_count":16,"citation_normalized_percentile":{"value":0.8390459,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":97},"biblio":{"volume":"28","issue":"2","first_page":"243","last_page":"251"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11314","display_name":"Clinical Laboratory Practices and Quality Control","score":0.45829999446868896,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11314","display_name":"Clinical Laboratory Practices and Quality Control","score":0.45829999446868896,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10373","display_name":"Renal Transplantation Outcomes and Treatments","score":0.2842000126838684,"subfield":{"id":"https://openalex.org/subfields/2747","display_name":"Transplantation"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.10999999940395355,"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/rapamycin","display_name":"rapamycin","score":1.0},{"id":"https://openalex.org/keywords/therapeutic-drug-monitoring","display_name":"therapeutic drug monitoring","score":0.9990000128746033},{"id":"https://openalex.org/keywords/microparticle-enzyme-immunoassay","display_name":"microparticle enzyme immunoassay","score":0.906000018119812},{"id":"https://openalex.org/keywords/chemiluminescent-microparticle-immunoassay","display_name":"chemiluminescent microparticle immunoassay","score":0.9789999723434448},{"id":"https://openalex.org/keywords/lc-ms-ms","display_name":"LC-MS/MS","score":0.765999972820282},{"id":"https://openalex.org/keywords/proficiency-testing","display_name":"proficiency testing","score":0.9259999990463257},{"id":"https://openalex.org/keywords/whole-blood-drug-concentration","display_name":"whole blood drug concentration","score":0.6899999976158142},{"id":"https://openalex.org/keywords/transplant-immunosuppression","display_name":"transplant immunosuppression","score":0.8949999809265137}],"concepts":[{"id":"https://openalex.org/C2777921159","wikidata":"https://www.wikidata.org/wiki/Q32089","display_name":"Sirolimus","level":2,"score":0.8264638185501099},{"id":"https://openalex.org/C61797465","wikidata":"https://www.wikidata.org/wiki/Q1188986","display_name":"Term (time)","level":2,"score":0.7058814764022827},{"id":"https://openalex.org/C2780272996","wikidata":"https://www.wikidata.org/wiki/Q1261151","display_name":"Therapeutic drug monitoring","level":3,"score":0.670452356338501},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.5223544836044312},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.4810793101787567},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4471759498119354},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4014959931373596},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.3924703001976013},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.34568336606025696},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.2556270360946655},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.23177498579025269},{"id":"https://openalex.org/C121332964","wikidata":"https://www.wikidata.org/wiki/Q413","display_name":"Physics","level":0,"score":0.06605100631713867},{"id":"https://openalex.org/C62520636","wikidata":"https://www.wikidata.org/wiki/Q944","display_name":"Quantum mechanics","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D002853","descriptor_name":"Chromatography, Liquid","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006084","descriptor_name":"Graft Rejection","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007118","descriptor_name":"Immunoassay","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D007124","descriptor_name":"Immunoenzyme Techniques","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007166","descriptor_name":"Immunosuppressive Agents","qualifier_ui":"Q000032","qualifier_name":"analysis","is_major_topic":true},{"descriptor_ui":"D007166","descriptor_name":"Immunosuppressive Agents","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":false},{"descriptor_ui":"D016030","descriptor_name":"Kidney Transplantation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016903","descriptor_name":"Drug Monitoring","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D020123","descriptor_name":"Sirolimus","qualifier_ui":"Q000032","qualifier_name":"analysis","is_major_topic":true},{"descriptor_ui":"D020123","descriptor_name":"Sirolimus","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":false},{"descriptor_ui":"D053719","descriptor_name":"Tandem Mass Spectrometry","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1111/ctr.12305","doi":"https://doi.org/10.1111/ctr.12305","is_oa":false,"landing_page_url":"https://doi.org/10.1111/ctr.12305","pdf_url":null,"source":{"id":"https://openalex.org/S4210215907","display_name":"Clinical Transplantation","issn_l":"0902-0063","issn":["0902-0063","1399-0012"],"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-70","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Transplantation","raw_type":"journal-article"},{"id":"pmid:24476346","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/24476346","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":"Clinical transplantation","raw_type":"Comparative Study"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":0.9391000270843506}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320307765","display_name":"Pfizer","ror":"https://ror.org/01xdqrp08"}],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":26,"referenced_works":["https://openalex.org/W4302992","https://openalex.org/W1976350400","https://openalex.org/W1980875248","https://openalex.org/W1988220942","https://openalex.org/W1990817630","https://openalex.org/W1993493438","https://openalex.org/W1999043049","https://openalex.org/W2009680608","https://openalex.org/W2013146832","https://openalex.org/W2015479549","https://openalex.org/W2025672561","https://openalex.org/W2034669933","https://openalex.org/W2038460944","https://openalex.org/W2040511904","https://openalex.org/W2052828036","https://openalex.org/W2059333451","https://openalex.org/W2059509591","https://openalex.org/W2061849028","https://openalex.org/W2064380726","https://openalex.org/W2075421237","https://openalex.org/W2088587136","https://openalex.org/W2112181215","https://openalex.org/W2128255624","https://openalex.org/W2130923901","https://openalex.org/W2142288396","https://openalex.org/W2148724358"],"related_works":["https://openalex.org/W1988220942","https://openalex.org/W2065908758","https://openalex.org/W1896054309","https://openalex.org/W4302992","https://openalex.org/W1990817630","https://openalex.org/W2013146832","https://openalex.org/W1992313078","https://openalex.org/W2085223044","https://openalex.org/W2087534519","https://openalex.org/W2017968411"],"abstract_inverted_index":{"Results":[0],"of":[1,4,19,41,58,69,86,113,148,170,177,185],"therapeutic":[2],"monitoring":[3,176],"sirolimus":[5,59,178],"blood":[6],"concentrations":[7],"are":[8],"assay":[9,79,179],"and":[10,31,51,65,174,189,200],"laboratory":[11],"dependent.":[12],"This":[13],"study":[14],"compared":[15,74],"performance":[16],"over":[17,134],"time":[18,135],"the":[20,77,105,127,168,186],"IMx":[21],"microparticle":[22,28],"enzyme":[23],"immunoassay":[24,29,149],"(MEIA),":[25],"Architect":[26],"chemiluminescent":[27],"(CMIA),":[30],"liquid":[32],"chromatography":[33],"with":[34,55,75],"mass":[35],"spectrometric":[36],"detection":[37],"(LC/MS/MS)":[38],"as":[39],"part":[40],"a":[42,109,141],"proficiency":[43,172],"testing":[44,173],"scheme.":[45],"Pooled":[46],"samples":[47,53,72],"from":[48,97,119],"sirolimus-treated":[49],"patients":[50],"whole-blood":[52],"spiked":[54,125],"known":[56],"quantities":[57],"were":[60,73,157],"assayed":[61],"monthly":[62],"between":[63],"2004":[64],"2012.":[66,122],"When":[67],"results":[68,166],"pooled":[70],"patient":[71,153],"LC/MS/MS,":[76,137],"MEIA":[78,106,128,163],"showed":[80,129],"an":[81,130],"overall":[82],"mean":[83,110],"percent":[84,111],"bias":[85,112,133],"-2.3%":[87],"\u00b1":[88,115],"11.2%":[89],"that,":[90],"although":[91],"initially":[92],"positive,":[93],"became":[94],"increasingly":[95,131],"negative":[96,132],"2007":[98,120],"through":[99,121],"2009.":[100],"The":[101],"CMIA,":[102],"which":[103],"replaced":[104],"assay,":[107],"had":[108],"21.9%":[114],"12.3%,":[116],"remaining":[117],"stable":[118,142],"Similarly,":[123],"for":[124],"samples,":[126,154],"vs.":[136],"whereas":[138],"CMIA":[139,155],"maintained":[140],"positive":[143],"bias.":[144],"Based":[145],"on":[146,151,198],"comparison":[147],"measurements":[150],"individual":[152],"values":[156],"more":[158],"than":[159,162],"25%":[160],"higher":[161],"values.":[164],"These":[165],"highlight":[167],"importance":[169],"continued":[171],"regular":[175],"performance.":[180],"Clinicians":[181],"must":[182],"be":[183],"aware":[184],"methodology":[187],"used":[188],"adjust":[190],"target":[191],"levels":[192],"accordingly":[193],"to":[194],"avoid":[195],"potential":[196],"effects":[197],"efficacy":[199],"toxicity.":[201]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":2},{"year":2019,"cited_by_count":3},{"year":2017,"cited_by_count":2},{"year":2016,"cited_by_count":3},{"year":2015,"cited_by_count":2},{"year":2014,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}