{"id":"https://openalex.org/W2067294658","doi":"https://doi.org/10.1016/j.clinthera.2013.06.010","title":"Are Hepatic Impairment Studies Necessary for Therapeutic Proteins?","display_name":"Are Hepatic Impairment Studies Necessary for Therapeutic Proteins?","publication_year":2013,"publication_date":"2013-07-25","ids":{"openalex":"https://openalex.org/W2067294658","doi":"https://doi.org/10.1016/j.clinthera.2013.06.010","mag":"2067294658","pmid":"https://pubmed.ncbi.nlm.nih.gov/23891362"},"language":"en","primary_location":{"id":"doi:10.1016/j.clinthera.2013.06.010","doi":"https://doi.org/10.1016/j.clinthera.2013.06.010","is_oa":false,"landing_page_url":"https://doi.org/10.1016/j.clinthera.2013.06.010","pdf_url":null,"source":{"id":"https://openalex.org/S185879095","display_name":"Clinical Therapeutics","issn_l":"0149-2918","issn":["0149-2918","1879-114X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Therapeutics","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/A5061426227","display_name":"Jun Yang","orcid":"https://orcid.org/0000-0002-4233-3220","observed_orcids":["https://orcid.org/0000-0002-4233-3220"]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jun Yang","raw_affiliation_strings":["Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland. Electronic address: jun.yang@fda.hhs.gov","Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland. Electronic address: jun.yang@fda.hhs.gov","institution_ids":["https://openalex.org/I1320320070"]},{"raw_affiliation_string":"Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland","institution_ids":["https://openalex.org/I1320320070"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5065397717","display_name":"Stacy Shifflett Shord","orcid":"https://orcid.org/0009-0000-9497-1171","observed_orcids":["https://orcid.org/0009-0000-9497-1171"]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Stacy Shord","raw_affiliation_strings":["Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland","institution_ids":["https://openalex.org/I1320320070"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5100675711","display_name":"Hong Zhao","orcid":"https://orcid.org/0000-0003-4616-3123","observed_orcids":["https://orcid.org/0000-0003-4616-3123","https://orcid.org/0009-0003-0543-2689","https://orcid.org/0009-0008-0111-7995"]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Hong Zhao","raw_affiliation_strings":["Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland","institution_ids":["https://openalex.org/I1320320070"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Yuxin Men","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Yuxin Men","raw_affiliation_strings":["Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland","institution_ids":["https://openalex.org/I1320320070"]}]},{"author_position":"last","author":{"id":null,"display_name":"Atiqur Rahman","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Atiqur Rahman","raw_affiliation_strings":["Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland","institution_ids":["https://openalex.org/I1320320070"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I1320320070"],"apc_list":{"value":4240,"currency":"USD","value_usd":4240},"apc_paid":null,"fwci":0.9215,"has_fulltext":false,"cited_by_count":13,"citation_normalized_percentile":{"value":0.75877055,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":97},"biblio":{"volume":"35","issue":"9","first_page":"1444","last_page":"1451"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.47269999980926514,"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"}},"topics":[{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.47269999980926514,"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/T12547","display_name":"Pharmaceutical studies and practices","score":0.23739999532699585,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"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/T10375","display_name":"Pharmacogenetics and Drug Metabolism","score":0.09430000185966492,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/liver-dysfunction","display_name":"liver dysfunction","score":0.9129999876022339},{"id":"https://openalex.org/keywords/therapeutic-proteins","display_name":"therapeutic proteins","score":0.9919999837875366},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.9639999866485596},{"id":"https://openalex.org/keywords/drug-safety-in-liver-disease","display_name":"drug safety in liver disease","score":0.5830000042915344},{"id":"https://openalex.org/keywords/drotrecogin-alfa","display_name":"drotrecogin alfa","score":0.8759999871253967},{"id":"https://openalex.org/keywords/biologics-license-application","display_name":"Biologics License Application","score":0.640999972820282},{"id":"https://openalex.org/keywords/dose-adjustment","display_name":"dose adjustment","score":0.48100000619888306}],"concepts":[{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.9079364538192749},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8746664524078369},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.5301051139831543},{"id":"https://openalex.org/C2908647359","wikidata":"https://www.wikidata.org/wiki/Q2625603","display_name":"Population","level":2,"score":0.4786423444747925},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.4493723511695862},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.36912810802459717},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000911","descriptor_name":"Antibodies, Monoclonal","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D000922","descriptor_name":"Immunotoxins","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004798","descriptor_name":"Enzymes","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008107","descriptor_name":"Liver Diseases","qualifier_ui":"Q000378","qualifier_name":"metabolism","is_major_topic":true},{"descriptor_ui":"D011506","descriptor_name":"Proteins","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016207","descriptor_name":"Cytokines","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D057127","descriptor_name":"Single-Chain Antibodies","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D057487","descriptor_name":"Enzyme Therapy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D058990","descriptor_name":"Molecular Targeted Therapy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1016/j.clinthera.2013.06.010","doi":"https://doi.org/10.1016/j.clinthera.2013.06.010","is_oa":false,"landing_page_url":"https://doi.org/10.1016/j.clinthera.2013.06.010","pdf_url":null,"source":{"id":"https://openalex.org/S185879095","display_name":"Clinical Therapeutics","issn_l":"0149-2918","issn":["0149-2918","1879-114X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Therapeutics","raw_type":"journal-article"},{"id":"pmid:23891362","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/23891362","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 therapeutics","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.9940000176429749,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":23,"referenced_works":["https://openalex.org/W342872802","https://openalex.org/W1969942339","https://openalex.org/W1970875728","https://openalex.org/W2011042500","https://openalex.org/W2011055527","https://openalex.org/W2017264099","https://openalex.org/W2024985051","https://openalex.org/W2027894892","https://openalex.org/W2041871645","https://openalex.org/W2042916360","https://openalex.org/W2044160586","https://openalex.org/W2062756251","https://openalex.org/W2081021748","https://openalex.org/W2082177367","https://openalex.org/W2124050480","https://openalex.org/W2131082981","https://openalex.org/W2144895900","https://openalex.org/W2145533061","https://openalex.org/W2152734037","https://openalex.org/W2164634712","https://openalex.org/W2168860536","https://openalex.org/W2176100822","https://openalex.org/W2403688157"],"related_works":["https://openalex.org/W4406271953","https://openalex.org/W4298088915","https://openalex.org/W3083828412","https://openalex.org/W2053879286","https://openalex.org/W2068904135","https://openalex.org/W2016312308","https://openalex.org/W2153274336","https://openalex.org/W2801635261","https://openalex.org/W1545834154","https://openalex.org/W1988546203"],"abstract_inverted_index":null,"counts_by_year":[{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":1},{"year":2021,"cited_by_count":2},{"year":2020,"cited_by_count":2},{"year":2019,"cited_by_count":1},{"year":2016,"cited_by_count":3},{"year":2015,"cited_by_count":2}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}