Design and conduct considerations for studies in patients with hepatic impairment

P Ravenstijn, M Chetty, P Manchandani… - Clinical and …, 2023 - Wiley Online Library
Despite the liver being the primary site for clearance of xenobiotics utilizing a myriad of
mechanisms ranging from cytochrome P450 enzyme pathways, glucuronidation, and biliary …

Hepatic impairment physiologically based pharmacokinetic model development: current challenges

AN Han, BR Han, T Zhang, T Heimbach - Current Pharmacology Reports, 2021 - Springer
Purpose This review summarizes the development processes of hepatic impairment (HI)
PBPK models, examines current challenges, and proposes potential solutions. Recent …

Predicting changes in the pharmacokinetics of CYP3A‐metabolized drugs in hepatic impairment and insights into factors driving these changes

MK Ladumor, F Storelli, X Liang, Y Lai… - CPT …, 2023 - Wiley Online Library
Physiologically based pharmacokinetic models, populated with drug‐metabolizing enzyme
and transporter (DMET) abundance, can be used to predict the impact of hepatic impairment …

time to revisit Child‐Pugh score as the basis for predicting drug clearance in hepatic impairment

E El‐Khateeb, AS Darwich, B Achour… - Alimentary …, 2021 - Wiley Online Library
Background Prescription information for many drugs entering the market lacks dosage
guidance for hepatic impairment. Dedicated studies for assessing the fate of drugs in hepatic …

Effect of liver disease on dose optimization

TF Blaschke - International Congress Series, 2001 - Elsevier
Many narrow therapeutic index drugs are eliminated primarily by hepatic metabolism.
Selecting the proper dosing regimen for such drugs in the presence of liver disease is an …

Guide to drug dosage in hepatic disease

NM Bass, RL Williams - Clinical pharmacokinetics, 1988 - Springer
After entry of a drug into the systemic circulation, duration and intensity of drug action is
determined to a large extent by the rate at which the drug is eliminated from the body. Drug …

Pharmacokinetics and dosage adjustment in patients with hepatic dysfunction

RK Verbeeck - European journal of clinical pharmacology, 2008 - Springer
The liver plays a central role in the pharmacokinetics of the majority of drugs. Liver
dysfunction may not only reduce the blood/plasma clearance of drugs eliminated by hepatic …

Drug-induced liver disease and drug use considerations in liver disease

JW Kim, PV Phongsamran - Journal of Pharmacy Practice, 2009 - journals.sagepub.com
Chronic liver disease encompasses a large number of hepatic disorders. One of the most
important etiologies of liver disease is drug-induced liver disease, which is the leading …

Assessment of hepatic impairment and implications for pharmacokinetics of substance use treatment

AH Talal, CS Venuto, I Younis - Clinical pharmacology in drug …, 2017 - Wiley Online Library
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 …

Assessing Pharmacokinetics in Liver Disease: Challenges and Future Considerations for Classification of Hepatic Dysfunction and Use of In Silico Methods.

MD Sahre, D Guinn, A Ramamoorthy… - Journal of Clinical …, 2023 - search.ebscohost.com
The article discusses the challenges and future considerations in evaluating
pharmacokinetics (PK) in liver disease, particularly hepatic dysfunction (HI), and the benefit …