ReviewClinical pharmacology and therapeutics2018
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Review in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 203 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
203 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
- Trial
- 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
- Model-Informed Pediatric Dose Selection for Dapagliflozin by Incorporating Developmental Changes.CPT: pharmacometrics & systems pharmacology · 2021Trial
- Physiologically-Based Pharmacokinetic Modeling of the Drug-Drug Interaction of the UGT Substrate Ertugliflozin Following Co-Administration with the UGT Inhibitor Mefenamic Acid.CPT: pharmacometrics & systems pharmacology · 2021Trial
- Preterm Physiologically Based Pharmacokinetic Model. Part II: Applications of the Model to Predict Drug Pharmacokinetics in the Preterm Population.Clinical pharmacokinetics · 2020Trial
- Application of an Open-Source Modular Framework for Pharmacokinetic, Pharmacodynamic, and Safety Simulations to Anti-Tuberculosis Drugs.CPT: pharmacometrics & systems pharmacology · 2026Article
- PBPK Modeling of Coproporphyrin I Reveals Frailty-Associated Changes in Hepatic OATP1B1 Function in Chinese Adults.Clinical pharmacokinetics · 2026Article
- 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
- Integrating Clinical Evidence with PBPK Modeling to Assess PPI-Clopidogrel-CYP2C19 Interactions in Chinese ACS Patients.Pharmaceutical research · 2026Observational
- Potential Therapeutic Roles of Icariin in Inflammatory Diseases: From Molecular Mechanisms to Clinical Translation Prospects.Antioxidants (Basel, Switzerland) · 2026Review
- Applications of artificial intelligence in nuclear medicine.Zeitschrift fur medizinische Physik · 2026Review
- Construction of a translational whole-body physiologically based pharmacokinetic model to investigate the biodistribution of lipid nanoparticle-based mRNA therapeutics for intracellular protein targets.Journal of pharmacokinetics and pharmacodynamics · 2026Article
- Beyond Body Weight: A Comprehensive Review of Allometric Scaling in Drug Development for Human Dose Predictions.Pharmaceutics · 2026Review
- Impact of Preclinical Verification in Physiologically Based Pharmacokinetic Modelling for First-in-Human Predictions: Application of a Published Model Building Strategy for Five Compounds.Clinical pharmacokinetics · 2026Article
- Development and Evaluation of a Physiologically Based Pharmacokinetic Model for Cipepofol Across Diverse Clinical Populations.Pharmaceutics · 2026Article
- Age-Driven Physiologically Based Pharmacokinetic Modeling of Empagliflozin: Toward Precision Dosing in Youth.ACS pharmacology & translational science · 2026Article
- Assessing transporter-mediated rifampin-linezolid interaction using physiologically-based pharmacokinetic modelling.British journal of clinical pharmacology · 2026Article
- Physiologically Based Pharmacokinetic Model to Predict Drug-Drug Interactions With the Antibody-Drug Conjugate Trastuzumab Deruxtecan.CPT: pharmacometrics & systems pharmacology · 2026Article
- Physiologically Based Pharmacokinetic Modeling of Elexacaftor/Tezacaftor/Ivacaftor in Infants With Cystic Fibrosis.CPT: pharmacometrics & systems pharmacology · 2026Article
143 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
34 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This work provides a perspective on the qualification and verification of physiologically based pharmacokinetic (PBPK) platforms/models intended for regulatory submission based on the collective experience of the Simcyp Consortium members. Examples of regulatory submission of PBPK analyses across various intended applications are presented and discussed. European Medicines Agency (EMA) and US Food and Drug Administration (FDA) recent draft guidelines regarding PBPK analyses and reporting are encouraging, and to advance the use and acceptability of PBPK analyses, more clarity and flexibility are warranted.
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.