Article In Press | Published on: May 09, 2026
Volume: 3, Issue: 1
1. Mahmood Clinical Pharmacology Consultancy, LLC. 1709 Piccard Dr, Rockville, MD 20850, USA.
Corresponding Author: Iftekhar Mahmood, Mahmood Clinical Pharmacology Consultancy, LLC. 1709 Piccard Dr, Rockville, MD 20850, USA.
Citation: I. Mahmood. (2026). Prediction of Drug Clearance in Subjects with Varying Degrees of Hepatic Impairment Using Albumin or Bilirubin or Albumin-Bilirubin Score. Journal of Bio-Med and Clinical Research. RPC Publishers. 3(1); 1-10.
Copyright: © 2026 Iftekhar Mahmood, this is an open-Access article distributed under the Terms of the Creative Commons Attribution License, which permits unrestricted use, Distribution, and reproduction in any medium, provided the original author and source are credited.
Hepatic impairment is classified as mild, moderate, and severe based on either Child-Pugh or National Cancer Institute (NCI) classification system. Another classification system based on bilirubin and albumin levels known as albumin-bilirubin (ALBI) scoring system has been proposed mainly for the patients with cancer with hepatic impairment. The objective of this study was to predict drug clearance in subjects with varying degrees of hepatic impairment using albumin or bilirubin or albumin-bilirubin (ALBI) score. There were thirty-five drugs with 64 observations (different degrees of hepatic impairment) in this study. The methods used to predict drug Clearance (CL) in subjects with hepatic impairment were bilirubin or albumin or ALBI score. Prediction fold-errors of 0.5-2, 0.5-1.5, and 0.7-1.3 were used for the assessment of the predictive performance of the proposed three methods. More than 90% observations were within 0.5-2-fold prediction error by all three methods. Based on albumin, bilirubin, and ALBI, 75.0%, 79.7%, and 89.1% observations were within 0.5-1.5-fold prediction error, respectively. ALBI particularly provided a good prediction in subjects with severe liver impairment (93.8% within 0.5-1.5 and 68.8% within 0.7-1.3-fold prediction error). All three approaches are simple. ALBI is suitable for the prediction of drug clearance in patients with hepatic impairment with or without cancer and is simple and accurate.
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