ReviewClinical pharmacology in drug development2017
Assessment of Hepatic Impairment and Implications for Pharmacokinetics of Substance Use Treatment.
Review in Clinical pharmacology in drug development, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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
21 citing papers in PubMed, 41 citations in OpenAlex.
- The Effect of Various Degrees of Renal or Hepatic Impairment on the Pharmacokinetic Properties of Once-Weekly Insulin Icodec.Clinical pharmacokinetics · 2024Trial
- Niraparib PBPK modeling to predict optimal dosage in patients with hepatic impairment.Frontiers in pharmacology · 2026Article
- Review
- How Clinical Pharmacology Can Support Clinical Trial Diversity and Inclusion.Clinical and translational science · 2025Review
- 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
- New Insights Into Hepatic Impairment (HI) Trials.Clinical and translational science · 2025Review
- Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.The AAPS journal · 2023Review
- Design and conduct considerations for studies in patients with hepatic impairment.Clinical and translational science · 2023Review
- Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non-orphan drugs approved by the FDA.Clinical and translational science · 2022Article
- Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications-A Systematic Analysis of SmPCs/PI of Major Drug Markets.Journal of clinical medicine · 2022Article
- Ferritin as an indicator of disease activity in Hodgkin lymphoma in pediatric patients.American journal of blood research · 2022Article
- Pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment.Cancer chemotherapy and pharmacology · 2021Article
- Non-uniformity of Changes in Drug-Metabolizing Enzymes and Transporters in Liver Cirrhosis: Implications for Drug Dosage Adjustment.Molecular pharmaceutics · 2021Article
- Gene Expression and Protein Abundance of Hepatic Drug Metabolizing Enzymes in Liver Pathology.Pharmaceutics · 2021Article
- Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective.Clinical pharmacology and therapeutics · 2021Article
- Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Laboratory Reference Ranges and Testing Intervals Work Group.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021Review
- Role of Pharmacogenetics in Adverse Drug Reactions: An Update towards Personalized Medicine.Frontiers in pharmacology · 2021Review
- Pharmacokinetics and safety of olaparib in patients with advanced solid tumours and mild or moderate hepatic impairment.British journal of clinical pharmacology · 2020Article
- Article
- Influence of Obesity and Type 2 Diabetes Mellitus on the Pharmacokinetics of Tramadol After Single Oral Dose Administration.European journal of drug metabolism and pharmacokinetics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
Abstract
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-stage 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-Pugh 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.
Indexed as
Identifiers
What Socratic 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 Socratic graph.