ArticleClinical pharmacology and therapeutics2021
Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective.
Article in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
73 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Clinical Exploration and Physiologically Based Modelling of the Impact of Hepatic Impairment on Entrectinib Pharmacokinetics.Clinical pharmacokinetics · 2025Trial
- Physiologically based pharmacokinetic modelling to predict the clinical effect of CYP3A inhibitors/inducers on esaxerenone pharmacokinetics in healthy subjects and subjects with hepatic impairment.European journal of clinical pharmacology · 2022Trial
- Insights into Drug Absorption Impairment Mechanisms in Hepatic Impairment using Physiologically-based Pharmacokinetic Modelling: A Case Study with Nilotinib.The AAPS journal · 2026Article
- Understanding Pharmacokinetic Variability of Pomalidomide: A Physiologically Based Pharmacokinetic Analysis of Disease-Related Physiology, Ethnicity, Hepatic Impairment, Food Effects, Drug Interactions, and Smoking.Clinical pharmacokinetics · 2026Article
- Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.CPT: pharmacometrics & systems pharmacology · 2026Review
- PBPK modeling predicts rilzabrutinib dose adjustments using BTK occupancy for CYP3A4 interactions and hepatic impairment.Scientific reports · 2026Article
- An IQ Consortium Perspective on the FDA Guidance for Assessment of Pharmacokinetics in Participants With Impaired Renal Function.Clinical pharmacology and therapeutics · 2026Review
- Physiologically based pharmacokinetic modeling for optimal dosage prediction of statins and warfarin in patients with liver cirrhosis.European journal of clinical pharmacology · 2026Article
- Comprehensive Pathophysiology Repository for PBPK Modeling in Liver Cirrhosis: Quantifying Continuous Disease Progression and Population Variability.CPT: pharmacometrics & systems pharmacology · 2026Article
- Analysis of Current Industry Practices for Informing Dosing Recommendation for Patients With Renal Impairment.Clinical and translational science · 2026Review
- Niraparib PBPK modeling to predict optimal dosage in patients with hepatic impairment.Frontiers in pharmacology · 2026Article
- Physiologically Based Pharmacokinetic Modeling in Patients With Hepatic Impairment: Are Changes in Bosutinib Exposure Profiles Driven by Altered Absorption or Distribution?CPT: pharmacometrics & systems pharmacology · 2026Article
- Using Physiologically Based Pharmacokinetic Modeling and Simulations to Predict Antihypertensive Drug Doses in Cirrhotic Patients.Journal of clinical pharmacology · 2026Article
- Enhancing therapeutic strategies and drug development for patients with kidney disease.Expert opinion on drug safety · 2026Review
- Physiologically-based pharmacokinetic model to predict loading dose polymyxin B exposure in critically ill patients with sepsis.Frontiers in pharmacology · 2026Article
- Advances in Cytotoxicity Testing: From In Vitro Assays to In Silico Models.International journal of molecular sciences · 2025Review
- PBPK Modeling to Predict Clinical Drug-Drug Interaction and Impact of Hepatic Impairment for an ADC With the Payload Auristatin F-Hydroxypropylamide.CPT: pharmacometrics & systems pharmacology · 2025Article
- Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib.Pharmaceutics · 2025Article
- A Comprehensive Physiologically Based Pharmacokinetic Framework of Ofloxacin: Predicting Disposition in Renal Impairment.Pharmaceutics · 2025Article
13 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The predictive performance of physiologically-based pharmacokinetics (PBPK) models for pharmacokinetics (PK) in renal impairment (RI) and hepatic impairment (HI) populations was evaluated using clinical data from 29 compounds with 106 organ impairment study arms were collected from 19 member companies of the International Consortium for Innovation and Quality in Pharmaceutical Development. Fifty RI and 56 HI study arms with varying degrees of organ insufficiency along with control populations were evaluated. For RI, the area under the curve (AUC) ratios of RI to healthy control were predicted within twofold of the observed ratios for > 90% (N = 47/50 arms). For HI, > 70% (N = 43/56 arms) of the hepatically impaired to healthy control AUC ratios were predicted within twofold. Inaccuracies, typically overestimation of AUC ratios, occurred more in moderate and severe HI. PBPK predictions can help determine the need and timing of organ impairment study. It may be suitable for predicting the impact of RI on PK of drugs predominantly cleared by metabolism with varying contribution of renal clearance. PBPK modeling may be used to support mild impairment study waivers or clinical study design.
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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.