ReviewPharmaceutical research2022
Quality Assurance of PBPK Modeling Platforms and Guidance on Building, Evaluating, Verifying and Applying PBPK Models Prudently under the Umbrella of Qualification: Why, When, What, How and By Whom?
Review in Pharmaceutical research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 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
28 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A Systematic Review of Published Physiologically Based Pharmacokinetic Models for Drug Excretion Into Human Breastmilk: Knowledge Gaps and Opportunities to Optimize Reporting and Modeling Practices.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- A phase 1 evaluation of inhaled oxytocin: Physiologically-based pharmacokinetic model informed dosing of a novel heat-stable oxytocin delivery system.British journal of clinical pharmacology · 2026Trial
- Development of an isavuconazole physiologically-based pharmacokinetic model for adult and pediatric populations.Journal of pharmacokinetics and pharmacodynamics · 2026Article
- Physiologically based pharmacokinetic modeling of cefotaxime to inform pediatric dosing in renal impairment.European journal of clinical pharmacology · 2026Article
- Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.CPT: pharmacometrics & systems pharmacology · 2026Review
- Development of a model to predict nicotine pharmacokinetics from oral nicotine pouches.Scientific reports · 2026Article
- Mechanistic Modelling of Lidocaine and Prilocaine Absorption from EMLA Cream upon Topical Application using Physiologically Based Pharmacokinetic Modelling.AAPS PharmSciTech · 2025Article
- Optimization of Bottom-Up PBPK Model Development in SIMCYP via Retrospective Analysis of Clinical Human PK Data.Clinical and translational science · 2025Article
- A Novel Workflow for Non-Animal PBK Modelling of UV Filters: Oxybenzone as a Case Study.Pharmaceuticals (Basel, Switzerland) · 2025Article
- A Mechanistic Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling Approach Informed by In Vitro and Clinical Studies for Topical Administration of Adapalene Gels.Pharmaceutics · 2025Article
- Precision Medicine in Oncology: Imatinib Dosing in the Obese Cancer Population Using Virtual Clinical Trials.CPT: pharmacometrics & systems pharmacology · 2025Article
- Application of Machine Learning and Mechanistic Modeling to Predict Intravenous Pharmacokinetic Profiles in Humans.Journal of medicinal chemistry · 2025Article
- Current Use of Physiologically Based Pharmacokinetic modeling in New Medicinal Product Approvals at EMA.Clinical pharmacology and therapeutics · 2025Review
- Development and Application of Physiologically-Based Pharmacokinetic Model to Predict Systemic and Organ Exposure of Colorectal Cancer Drugs.Pharmaceutics · 2025Article
- Physiologically Based Pharmacokinetic Modeling and Dose Optimization of Linezolid in Pediatric Patients With Renal Impairment.Drug design, development and therapy · 2025Article
- PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report.Molecular pharmaceutics · 2024Review
- A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator.CPT: pharmacometrics & systems pharmacology · 2024Article
- Physiologically-based pharmacokinetic modeling predicts the drug interaction potential of GLS4 in co-administered with ritonavir.CPT: pharmacometrics & systems pharmacology · 2024Article
- The Biology and Biochemistry of Kynurenic Acid, a Potential Nutraceutical with Multiple Biological Effects.International journal of molecular sciences · 2024Review
- Towards More Robust Evaluation of the Predictive Performance of Physiologically Based Pharmacokinetic Models: Using Confidence Intervals to Support Use of Model-Informed Dosing in Clinical Care.Clinical pharmacokinetics · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Modeling and simulation emerges as a fundamental asset of drug development. Mechanistic modeling builds upon its strength to integrate various data to represent a detailed structural knowledge of a physiological and biological system and is capable of informing numerous drug development and regulatory decisions via extrapolations outside clinically studied scenarios. Herein, physiologically based pharmacokinetic (PBPK) modeling is the fastest growing branch, and its use for particular applications is already expected or explicitly recommended by regulatory agencies. Therefore, appropriate applications of PBPK necessitates trust in the predictive capability of the tool, the underlying software platform, and related models. That has triggered a discussion on concepts of ensuring credibility of model-based derived conclusions. Questions like 'why', 'when', 'what', 'how' and 'by whom' remain open. We seek for harmonization of recent ideas, perceptions, and related terminology. First, we provide an overview on quality assurance of PBPK platforms with the two following concepts. Platform validation: ensuring software integrity, security, traceability, correctness of mathematical models and accuracy of algorithms. Platform qualification: demonstrating the predictive capability of a PBPK platform within a particular context of use. Second, we provide guidance on executing dedicated PBPK studies. A step-by-step framework focuses on the definition of the question of interest, the context of use, the assessment of impact and risk, the definition of the modeling strategy, the evaluation of the platform, performing model development including model building, evaluation and verification, the evaluation of applicability to address the question, and the model application under the umbrella of a qualified platform.
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.