ArticleCPT: pharmacometrics & systems pharmacology2021
Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility.
Article in CPT: pharmacometrics & systems pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 papers, 3 of them syntheses 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
84 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Translation readiness of model-based synthetic tabular data in healthcare: a systematic review and governance audit.Journal of the American Medical Informatics Association : JAMIA · 2026Pooled it
- In Silico Clinical Trials in Drug Development: A Systematic Review.Therapeutic innovation & regulatory science · 2026Pooled it
- Update on antithrombotic therapy and body mass: a clinical consensus statement of the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy and the European Society of Cardiology Working Group on Thrombosis.European heart journal. Cardiovascular pharmacotherapy · 2024Pooled it
- Bioequivalence study of vonoprazan fumarate tablets in healthy Chinese subjects: a randomized, open-label, two-period crossover trial.Frontiers in pharmacology · 2026Trial
- Overview of Regulatory Guidelines Related to Methods and Models for Small Populations.Clinical pharmacology and therapeutics · 2026Review
- Review
- Artificial intelligence-driven digital twins in Pharma 4.0: transforming smart manufacturing, predictive quality assurance, and personalized drug delivery.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026Review
- The 95% CDIRAs, a Credible Interval Based Method to Capture Uncertainty in Population Modeling: Pharmacokinetics Versus Sum of Exponentials Case Study.CPT: pharmacometrics & systems pharmacology · 2026Article
- Quantitative Systems Pharmacology (QSP): Bridging Biology and Mechanism with Clinical Drug Development Decisions.Journal of clinical pharmacology · 2026Review
- In silico optimization of regenerative cell therapy in the infarcted human ventricles to mitigate arrhythmic burden.Stem cell reports · 2026Article
- Does Changing the Context of Use Change the Value Proposition of CiPA?Clinical pharmacology and therapeutics · 2026Article
- Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.CPT: pharmacometrics & systems pharmacology · 2026Review
- T-World Virtual Human Cardiomyocyte. II. Organ-Scale Simulations and Applications.Circulation research · 2026Article
- From FAIR to CURE: guidelines for computational models of biological systems.NPJ systems biology and applications · 2026Review
- Artificial intelligence for clinical trial design, conduct, and analysis: a narrative review.ESMO real world data and digital oncology · 2026Review
- Toward cardiac electrophysiology digital twins with an efficient open source scalable solver on GPU clusters.Scientific reports · 2026Article
- Validating Physiologically-Based Pharmacokinetic Models Using the Continuous Ranked Probability Score: Beyond Being Correct on Average.CPT: pharmacometrics & systems pharmacology · 2026Article
- Organ-on-a-Chip Technology and Global Multi-Omics: Current Applications and Future Directions.MedComm · 2026Review
- NX210c Demonstrates Therapeutic Potential to Restore Blood-Brain Barrier in a QSP Model of Relapsing-Remitting Multiple Sclerosis.International journal of molecular sciences · 2026Article
- Airway quantifications of bronchitis patients with photon-counting and energy-integrating computed tomography.Journal of medical imaging (Bellingham, Wash.) · 2026Article
24 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
20 authors.
Funding
Abstract
The value of in silico methods in drug development and evaluation has been demonstrated repeatedly and convincingly. While their benefits are now unanimously recognized, international standards for their evaluation, accepted by all stakeholders involved, are still to be established. In this white paper, we propose a risk-informed evaluation framework for mechanistic model credibility evaluation. To properly frame the proposed verification and validation activities, concepts such as context of use, regulatory impact and risk-based analysis are discussed. To ensure common understanding between all stakeholders, an overview is provided of relevant in silico terminology used throughout this paper. To illustrate the feasibility of the proposed approach, we have applied it to three real case examples in the context of drug development, using a credibility matrix currently being tested as a quick-start tool by regulators. Altogether, this white paper provides a practical approach to model evaluation, applicable in both scientific and regulatory evaluation contexts.
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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.