ArticleClinical pharmacokinetics2019
Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them.
Article in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
What it found
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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.
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Who cites it
42 citing papers in PubMed.
- From Design to Bedside: Brain-Targeted Engineered Nanoparticles and Predictive Modeling for Neurodegenerative Diseases Therapeutics.Pharmaceutical research · 2026Review
- Virtual bioequivalence-guided PBBM prediction for ibuprofen/diphenhydramine citrate tablets: impact of dissolution variability and clinical standard development.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026Article
- Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.CPT: pharmacometrics & systems pharmacology · 2026Review
- Optimizing Venous Thromboembolism Prophylaxis in Burn Patients Using Enoxaparin Through PBPK Modeling.CPT: pharmacometrics & systems pharmacology · 2026Article
- PKRxiv: A Best Practice Model for Advancing Pharmacoequity Through Open Pharmacokinetic Data Sharing.Clinical pharmacology and therapeutics · 2026Article
- Impact of Obesity and MASH on Zonal Hepatocellular Statin Exposure: Pharmacodynamic Insights From a Permeability-Limited Multicompartment Liver Model.CPT: pharmacometrics & systems pharmacology · 2026Article
- Article
- A Physiologically Based Pharmacokinetic Model for the Prediction of Plasma and Bone Tissue Exposure after Prophylactic Administration of Ampicillin/Sulbactam in Patients with Osteonecrosis of the Jaw.Clinical pharmacokinetics · 2025Article
- Predicting the developmental toxicity of 8-methyl-benzo[a]pyrene (BaP) by physiologically based kinetic (PBK) modeling-facilitated reverse dosimetry and read-across from BaP.Archives of toxicology · 2025Article
- Drug Interaction PBPK Modeling: Review of the Literature Exposes the Need for Increased Verification of Model Inputs and Outputs as Part of Credibility Assessment.Clinical and translational science · 2025Review
- Evaluation of Solubility-Limited Absorption as a Surrogate to Predicting Positive Food Effect of BCS II/IV Drugs.Clinical pharmacokinetics · 2025Article
- Solubility-Limited Absorption Identified by a Simplified PBPK Model for the Prediction of Positive Food Effect for BCS II/IV Drugs.Clinical pharmacokinetics · 2025Article
- Physiologically Based Pharmacokinetic Model of Cefotaxime in Patients with Impaired Renal Function.Clinical pharmacokinetics · 2025Article
- Prediction of High-Dose Methotrexate Blood Concentration in Osteosarcoma Patients Using Machine Learning.Drug design, development and therapy · 2025Article
- Potential and challenges in application of physiologically based pharmacokinetic modeling in predicting diarrheal disease impact on oral drug pharmacokinetics.Drug metabolism and disposition: the biological fate of chemicals · 2025Review
- From hazard to risk prioritization: a case study to predict drug-induced cholestasis using physiologically based kinetic modeling.Archives of toxicology · 2024Article
- Parameter grouping and co-estimation in physiologically based kinetic models using genetic algorithms.Toxicological sciences : an official journal of the Society of Toxicology · 2024Article
- Research Landscape of Physiologically Based Pharmacokinetic Model Utilization in Different Fields: A Bibliometric Analysis (1999-2023).Pharmaceutical research · 2024Article
- Explaining in-vitro to in-vivo efficacy correlations in oncology pre-clinical development via a semi-mechanistic mathematical model.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Advancing Precision Medicine: A Review of Innovative In Silico Approaches for Drug Development, Clinical Pharmacology and Personalized Healthcare.Pharmaceutics · 2024Review
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
When scientifically well-founded, the mechanistic basis of physiologically based pharmacokinetic (PBPK) models can help reduce the uncertainty and increase confidence in extrapolations outside the studied scenarios or studied populations. However, it is not always possible to establish mechanistically credible PBPK models. Requirements to establishing confidence in PBPK models, and challenges to meeting these requirements, are presented in this article. Parameter non-identifiability is the most challenging among the barriers to establishing confidence in PBPK models. Using case examples of small molecule drugs, this article examines the use of hypothesis testing to overcome parameter non-identifiability issues, with the objective of enhancing confidence in the mechanistic basis of PBPK models and thereby improving the quality of predictions that are meant for internal decisions and regulatory submissions. When the mechanistic basis of a PBPK model cannot be established, we propose the use of simpler models or evidence-based approaches.
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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.