ReviewClinical and translational science2023
Design and conduct considerations for studies in patients with hepatic impairment.
Review in Clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Pooled it
- Single‑Dose Pharmacokinetics and Safety of the Oral Galectin‑3 Inhibitor, Selvigaltin (GB1211), in Participants with Hepatic Impairment.Clinical drug investigation · 2024Trial
- Detection and quantification of ezetimibe and its major glucuronide in patients with hepatic impairment via liquid chromatography-tandem mass spectrometry.Journal of pharmaceutical and biomedical analysis · 2026Article
- Application of the Child-Pugh Classification in Japanese Drug Labeling: A Cross-Sectional Analysis of Contraindications, Dose Recommendations, and Pharmacokinetic Rationale.Therapeutic innovation & regulatory science · 2026Article
- Article
- Effects of Hepatic or Renal Impairment on Pharmacokinetics of Fruquintinib.Journal of clinical pharmacology · 2025Article
- Pharmacokinetics, safety, and tolerability of fedratinib in adults with moderate and severe hepatic impairment: results from the phase 1 FEDR-CP-001 trial.Cancer chemotherapy and pharmacology · 2025Article
- Phase I Study to Evaluate the Effect of Hepatic Impairment on Pharmacokinetics and Safety of Tegoprazan, a Potassium Competitive Acid Blocker.Advances in therapy · 2025Article
- Effect of Hepatic Impairment or Renal Impairment on the Pharmacokinetics of Aficamten.Clinical pharmacokinetics · 2025Article
- New Insights Into Hepatic Impairment (HI) Trials.Clinical and translational science · 2025Review
- Reduced hepatic impairment study to evaluate pharmacokinetics and safety of zavegepant and to inform dosing recommendation for hepatic impairment.Clinical and translational science · 2024Article
- Simulating Healthy Participant Pharmacokinetics for Renal and Hepatic Impairment Studies: Retrospective Assessment of the Approach.The AAPS journal · 2024Article
- Pharmacokinetics, safety, and tolerability of BMS-986263, a lipid nanoparticle containing HSP47 siRNA, in participants with hepatic impairment.Clinical and translational science · 2023Article
- Design and conduct considerations for studies in patients with hepatic impairment.Clinical and translational science · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 excretion, there is a dearth of information available as to how the severity of hepatic impairment (HI) can alter drug absorption and disposition (i.e., pharmacokinetics [PK]) as well as their efficacy and safety or pharmacodynamics (PD). In general, regulatory agencies recommend conducting PK studies in subjects with HI when hepatic metabolism/excretion accounts for more than 20% of drug elimination or if the drug has a narrow therapeutic range. In this tutorial, we provide an overview of the global regulatory landscape, clinical measures for hepatic function assessment, methods to stage HI severity, and consequently the impact on labeling. In addition, we provide an in-depth practical guidance for designing and conducting clinical trials for patients with HI and on the application of modeling and simulation strategies in lieu of dedicated trials for dosing recommendations in patients with HI.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.