ReviewPharmaceutical research2022
Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective.
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 78 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.
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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
78 citing papers in PubMed, 133 citations in OpenAlex.
- Physiologically based pharmacokinetic modeling of diazepam: quantitative assessment of hepatic impairment and model-informed dose optimization in patients with liver cirrhosis.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Psychedelics and women's mental health: the effects of female sex hormones on psychedelics' efficacy and tolerability.Molecular psychiatry · 2026Review
- Advances in Machine Learning-Enhanced PBPK Models for Brain-Targeted Drug Delivery via Nanocarriers: A Comprehensive Review.Journal of functional biomaterials · 2026Review
- Machine Learning Enables Rapid Prediction of Acid-Reducing Agent Drug Interactions: A Streamlined Complement to PBPK Modeling.CPT: pharmacometrics & systems pharmacology · 2026Article
- Beyond Body Weight: A Comprehensive Review of Allometric Scaling in Drug Development for Human Dose Predictions.Pharmaceutics · 2026Review
- Development of an integrated physiologically based toxicokinetic-toxicodynamic model for quantitative prediction of polyhexamethylene guanidine-induced human toxicity.Archives of toxicology · 2026Article
- Review
- From simulation to application: enhancing preclinical evaluation of dissolvable microarray patches through PBPK modelling.Drug delivery and translational research · 2026Article
- Introduction to Single-cell Physiologically-Based Pharmacokinetic (scPBPK) Models.bioRxiv : the preprint server for biology · 2026Article
- Physiologically Based Pharmacokinetic Modeling of Digoxin in Adult and Pediatric Patients with Heart Failure.Pharmaceutics · 2026Article
- Neuroprotective effects of kojic acid and nano-kojic acid in experimental brain ischemia induced by bilateral common carotid artery occlusion.Iranian journal of basic medical sciences · 2026Article
- Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges.CPT: pharmacometrics & systems pharmacology · 2026Review
- Closing the loop: human-augmented, mechanistically enhanced AI for proactive management of drug-drug interactions.Frontiers in pharmacology · 2026Article
- A Physiologically-Based Pharmacokinetic Model to Predict Posaconazole Suspension Exposure and Optimize Dosing Strategy in Pediatric Hematology Patients: Incorporating the Impact of Food Intake.Drug design, development and therapy · 2026Article
- Pharmacokinetics of CYP2C19- and CYP3A4-Metabolized Drugs in Cirrhosis Using a Whole-Body PBPK Approach.Pharmaceutics · 2025Article
- Application of Physiologically-Based Pharmacokinetic Modeling to Support Drug Labeling: Prediction of CYP3A4-Mediated Pirtobrutinib-Drug Interactions.CPT: pharmacometrics & systems pharmacology · 2025Article
- Practical Pharmacokinetic-Pharmacodynamic Models in Oncology.Pharmaceutics · 2025Review
- Optimization of Bottom-Up PBPK Model Development in SIMCYP via Retrospective Analysis of Clinical Human PK Data.Clinical and translational science · 2025Article
- AI-powered programmable virtual humans toward human physiologically-based drug discovery.Drug discovery today · 2025Review
- The Evolution and Future Directions of PBPK Modeling in FDA Regulatory Review.Pharmaceutics · 2025Review
18 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
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK) analyses and physiologically based biopharmaceutics model(s) (PBBM(s)) have been issued. Workshops are routinely held, demonstrating substantial interest in applying these modeling approaches to address scientific questions in drug development. PBPK models and PBBMs have remarkably contributed to model-informed drug development (MIDD) such as anticipating clinical PK outcomes affected by extrinsic and intrinsic factors in general and specific populations. In this review, we proposed practical considerations for a "base" PBPK model construction and development, summarized current status, challenges including model validation and gaps in system models, and future perspectives in PBPK evaluation to assess a) drug metabolizing enzyme(s)- or drug transporter(s)- mediated drug-drug interactions b) dosing regimen prediction, sampling timepoint selection and dose validation in pediatric patients from newborns to adolescents, c) drug exposure in patients with renal and/or and hepatic organ impairment, d) maternal-fetal drug disposition during pregnancy, and e) pH-mediated drug-drug interactions in patients treated with proton pump inhibitors/acid-reducing agents (PPIs/ARAs) intended for gastric protection. Since PBPK can simulate outcomes in clinical studies with enrollment challenges or ethical issues, the impact of PBPK models on waivers and how to strengthen study waiver is discussed.
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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 OpenQuestion graph.