{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T14:25:54Z","timestamp":1778509554385,"version":"3.51.4"},"reference-count":45,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,3,6]],"date-time":"2017-03-06T00:00:00Z","timestamp":1488758400000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["2UM1AI069511"],"award-info":[{"award-number":["2UM1AI069511"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["5UM1AI106701\u201003"],"award-info":[{"award-number":["5UM1AI106701\u201003"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["5K23AI108355\u201002"],"award-info":[{"award-number":["5K23AI108355\u201002"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2017,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Although the liver is the primary site of metabolism and biliary excretion for many medications, data are limited on the liver's pharmacokinetic abilities in cirrhosis. Cirrhosis develops through collagen deposition, eventually culminating in end\u2010stage liver disease that compromises hepatic drug metabolism. Consequently, the US Food and Drug Administration (FDA) recommends evaluating the pharmacokinetics of medications in subjects with hepatic impairment if hepatic metabolism constitutes more than 20% of their elimination or if they have a narrow therapeutic range. A variety of noninvasive indices and radiologic procedures can be employed to assess hepatic drug metabolism and excretion. The Child\u2010Pugh score is the most commonly used scale for assessing hepatic impairment among drugs submitted for US FDA approval. The score, originally developed to guide operative mortality in patients undergoing hepatic resection, has not been modified since its inception 5 decades ago. Furthermore, the score was not originally intended to be a guide for potential dose modification in patients with hepatic impairment. These reasons, in combination with the availability of a variety of new imaging modalities and an enhanced understanding of hepatic biology, should foster the development of novel methods to assess the effect of hepatic impairment on liver drug metabolism.<\/jats:p>","DOI":"10.1002\/cpdd.336","type":"journal-article","created":{"date-parts":[[2017,3,6]],"date-time":"2017-03-06T15:25:23Z","timestamp":1488813923000},"page":"206-212","source":"Crossref","is-referenced-by-count":37,"title":["Assessment of Hepatic Impairment and Implications for Pharmacokinetics of Substance Use Treatment"],"prefix":"10.1002","volume":"6","author":[{"given":"Andrew H.","family":"Talal","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, Hepatology, and Nutrition Department of Medicine University at Buffalo  Buffalo NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles S.","family":"Venuto","sequence":"additional","affiliation":[{"name":"Center for Human Experimental Therapeutics University of Rochester  Rochester NY USA"},{"name":"AIDS Clinical Trials Group Pharmacology Specialty Laboratory New York State Center of Excellence in Bioinformatics and Life Sciences; School of Pharmacy and Pharmaceutical Sciences University at Buffalo  Buffalo NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Islam","family":"Younis","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,3,6]]},"reference":[{"key":"e_1_2_5_2_1_1","unstructured":"US FDA Center for Drug Evaluation and Research.Guidance for industry: Pharmacokinetics in patients with impaired hepatic function. Study design data analysis and impact on dosing and labeling.http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm064982.htm. Accessed July 18 2016."},{"key":"e_1_2_5_2_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.1800600817"},{"key":"e_1_2_5_2_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nri3623"},{"key":"e_1_2_5_2_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/jhep.2003.50038"},{"key":"e_1_2_5_2_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.52.8.1182"},{"key":"e_1_2_5_2_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0b013e328351db6e"},{"key":"e_1_2_5_2_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2008.302"},{"key":"e_1_2_5_2_8_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.113.055996"},{"key":"e_1_2_5_2_9_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.111.040592"},{"key":"e_1_2_5_2_10_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v18.i11.1166"},{"key":"e_1_2_5_2_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa044456"},{"key":"e_1_2_5_2_12_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2007.05.024"},{"key":"e_1_2_5_2_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2009.01.014"},{"key":"e_1_2_5_2_14_1","doi-asserted-by":"publisher","DOI":"10.7861\/clinmedicine.15-6-s83"},{"key":"e_1_2_5_2_15_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1201840109"},{"key":"e_1_2_5_2_16_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.06.036"},{"key":"e_1_2_5_2_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/jhbp.245"},{"key":"e_1_2_5_2_18_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI200522675"},{"key":"e_1_2_5_2_19_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1119964109"},{"key":"e_1_2_5_2_20_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2004.03.009"},{"key":"e_1_2_5_2_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2004.03.007"},{"key":"e_1_2_5_2_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.312"},{"key":"e_1_2_5_2_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2015.10.011"},{"key":"e_1_2_5_2_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2015.05.022"},{"key":"e_1_2_5_2_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2009.11.008"},{"key":"e_1_2_5_2_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23312"},{"key":"e_1_2_5_2_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ultrasmedbio.2010.07.005"},{"key":"e_1_2_5_2_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.12519"},{"issue":"10","key":"e_1_2_5_2_29_1","first-page":"17654","article-title":"Controlled attenuation parameter for assessment of hepatic steatosis grades: a diagnostic meta\u2010analysis","volume":"8","author":"Wang Y","year":"2015","journal-title":"Int J Clin Exp Med"},{"key":"e_1_2_5_2_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0011-3840(64)80003-4"},{"key":"e_1_2_5_2_31_1","doi-asserted-by":"publisher","DOI":"10.1053\/he.2000.5852"},{"key":"e_1_2_5_2_32_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000002877"},{"issue":"14","key":"e_1_2_5_2_33_1","first-page":"531s","article-title":"Comparison of Child\u2010Pugh (CP) criteria and NCI organ dysfunction working group (NCI\u2010ODWG) criteria for hepatic dysfunction (HD): implications for chemotherapy dosing","volume":"22","author":"Patel H","year":"2004","journal-title":"J Clin Oncol"},{"key":"e_1_2_5_2_34_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v22.i3.1260"},{"key":"e_1_2_5_2_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(63)80130-4"},{"key":"e_1_2_5_2_36_1","doi-asserted-by":"publisher","DOI":"10.1002\/mrm.10420"},{"key":"e_1_2_5_2_37_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.1990.tb00466.x"},{"key":"e_1_2_5_2_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/0016-5085(95)90700-9"},{"key":"e_1_2_5_2_39_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2013.78"},{"key":"e_1_2_5_2_40_1","doi-asserted-by":"publisher","DOI":"10.4065\/mcp.2009.0534"},{"key":"e_1_2_5_2_41_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1530-0277.1985.tb05558.x"},{"key":"e_1_2_5_2_42_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(00)00049-0"},{"key":"e_1_2_5_2_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(00)00050-7"},{"key":"e_1_2_5_2_44_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1521-0391.2013.12052.x"},{"key":"e_1_2_5_2_45_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-015-0238-6"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.336","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.336","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T18:21:28Z","timestamp":1696616488000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.336"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,3]]},"references-count":45,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2017,3]]}},"alternative-id":["10.1002\/cpdd.336"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.336","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,3]]}}}