ArticleCPT: pharmacometrics & systems pharmacology2021
A generic framework for the physiologically-based pharmacokinetic platform qualification of PK-Sim and its application to predicting cytochrome P450 3A4-mediated drug-drug interactions.
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 18 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- PBPK modeling: What is the role of CYP3A4 expression in the gastrointestinal tract to accurately predict first-pass metabolism?CPT: pharmacometrics & systems pharmacology · 2025Pooled it
- Artificial intelligence for drug delivery: Yesterday, today and tomorrow.Acta pharmaceutica Sinica. B · 2026Review
- Application of Physiologically-Based Pharmacokinetic Modeling to Support Drug Labeling: Prediction of CYP3A4-Mediated Pirtobrutinib-Drug Interactions.CPT: pharmacometrics & systems pharmacology · 2025Article
- Harnessing Open-Source Solutions: Insights From the First Open Systems Pharmacology (OSP) Community Conference.CPT: pharmacometrics & systems pharmacology · 2025Article
- Evaluation of BCRP-Related DDIs Between Methotrexate and Cyclosporin A Using Physiologically Based Pharmacokinetic Modelling.Drugs in R&D · 2025Article
- Exploring cotton plant compounds for novel treatments against brain-eating Naegleria fowleri: An In-silico approach.PloS one · 2025Article
- Identification of novel amides and alkaloids as putative inhibitors of dopamine transporter for schizophrenia using computer-aided virtual screening.Frontiers in pharmacology · 2025Article
- Computational analysis of Ayurvedic metabolites for potential treatment of drug-resistantFrontiers in cellular and infection microbiology · 2025Article
- Digital twin-enhanced three-organ microphysiological system for studying drug pharmacokinetics in pregnant women.Frontiers in pharmacology · 2025Article
- Model-Based Dose Selection of a Sphingosine-1-Phosphate Modulator, Etrasimod, in Patients with Various Degrees of Hepatic Impairment.Pharmaceutics · 2024Article
- Applied physiologically-based pharmacokinetic modeling to assess uridine diphosphate-glucuronosyltransferase-mediated drug-drug interactions for Vericiguat.CPT: pharmacometrics & systems pharmacology · 2024Article
- Physiologically Based Pharmacokinetic Modeling to Simulate CYP3A4-Mediated Drug-Drug Interactions for Pyrotinib.Advances in therapy · 2023Article
- Review
- Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?Clinical pharmacokinetics · 2023Review
- Development and Evaluation of a Physiologically Based Pharmacokinetic Model for Predicting Haloperidol Exposure in Healthy and Disease Populations.Pharmaceutics · 2022Article
- Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective.Pharmaceutical research · 2022Review
- Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator.CPT: pharmacometrics & systems pharmacology · 2022Article
- Physiologically-based pharmacokinetic modeling to predict CYP3A4-mediated drug-drug interactions of finerenone.CPT: pharmacometrics & systems pharmacology · 2022Article
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The success of applications of physiologically-based pharmacokinetic (PBPK) modeling in drug development and drug labeling has triggered regulatory agencies to demand rigorous demonstration of the predictive capability of the specific PBPK platform for a particular intended application purpose. The effort needed to comply with such qualification requirements exceeds the costs for any individual PBPK application. Because changes or updates of a PBPK platform would require (re-)qualification, a reliable and efficient generic qualification framework is needed. We describe the development and implementation of an agile and sustainable technical framework for automatic PBPK platform (re-)qualification of PK-Sim
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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.