ReviewClinical pharmacology and therapeutics2025
Current Use of Physiologically Based Pharmacokinetic modeling in New Medicinal Product Approvals at EMA.
Review in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed.
- 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
- From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs.Clinical pharmacology and therapeutics · 2026Review
- Innovative Clinical Pharmacology, Modeling, and Simulation Strategies for Accelerating Rare Disease Drug Development.Journal of clinical pharmacology · 2026Review
- A Review of Virtual Twins in Physiologically-Based Pharmacokinetic Modeling and Simulation.Clinical pharmacology and therapeutics · 2026Review
- Application of the Child-Pugh Classification in Japanese Drug Labeling: A Cross-Sectional Analysis of Contraindications, Dose Recommendations, and Pharmacokinetic Rationale.Therapeutic innovation & regulatory science · 2026Article
- Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.CPT: pharmacometrics & systems pharmacology · 2026Review
- Differences in Physiologically Based Pharmacokinetic Predictions between Software Platforms Can Be Clinically Relevant: Cases of Levornestrogel and Ethinylestradiol Concentrations with SIMCYP versus PK-Sim from a User Perspective.European journal of drug metabolism and pharmacokinetics · 2026Article
- From Models to Medicines: A Narrative History and Regulatory Perspective on the Translational Impact of Model-Informed Drug Development (MIDD).Clinical and translational science · 2026Review
- Utility of Modeling and Simulations in Drug Development: Contrasting Japan, US and UK Descriptions of PBPK Modeling from Package Inserts.The AAPS journal · 2026Article
- Population Pharmacokinetics and Model-Informed Dose Optimization of Teicoplanin in Adults with Hematological Malignancies.Pharmaceutics · 2026Article
- Need for NAMs: A systematic evidence synthesis revealing over half a century of drug development failure.NAM journal · 2026Article
- Scoping review of the role of pharmacometrics in model-informed drug development.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- Assessing Cytochrome P450 Drug Interaction Risk for Dordaviprone Using Physiologically Based Pharmacokinetic Modeling.CPT: pharmacometrics & systems pharmacology · 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
- Multi-scale computational modeling towards efficacy in radiopharmaceutical therapies while minimizing side effects: Modeling of amino acid infusion.PLoS computational biology · 2025Article
- Harnessing Open-Source Solutions: Insights From the First Open Systems Pharmacology (OSP) Community Conference.CPT: pharmacometrics & systems pharmacology · 2025Article
- Physiologically based pharmacokinetic modeling supports investigation of potential drug-drug interactions in the pre- and early post-hematopoietic stem cell transplantation stages.Frontiers in pharmacology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Physiologically Based Pharmacokinetic (PBPK) Models are routinely used in drug development and therefore appear frequently in marketing authorization applications (MAAs) to the European Medicines Agency (EMA). For a model to be a key source of evidence for a regulatory decision, it must be considered qualified for the intended use. Advice on the data expected to allow qualification of a PBPK model or platform is provided in the EMA Guideline on the reporting of PBPK modeling and simulation. The present study is an EMA review of the use of PBPK models in submitted MAAs in 2022 and 2023 focussing on the concept of qualification and the reasons why models were not considered qualified. A review of the 95 MAAs with a "full" legal basis approved during these years showed that 25 of them contained PBPK modeling. There were 65 proposed general areas of intended use for PBPK modeling identified across the applications, with the most common being a prediction of drug-drug interactions with enzymes or transporters (69%). Finally, this review showed that most of the models submitted in applications to EMA were not considered qualified for the intended use(s). The reasons identified for this are reported and the need for further EMA guidance, particularly around requirements for qualification of PBPK models, are discussed.
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.