Trial reportEuropean journal of clinical pharmacology2007
Linking preclinical and clinical whole-body physiologically based pharmacokinetic models with prior distributions in NONMEM.
Trial report in European journal of clinical pharmacology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 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.
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
22 citing papers in PubMed.
- Development and Application of a Mechanistic Pharmacokinetic Model for Simvastatin and its Active Metabolite Simvastatin Acid Using an Integrated Population PBPK Approach.Pharmaceutical research · 2015Trial
- Scaling of pharmacokinetics across paediatric populations: the lack of interpolative power of allometric models.British journal of clinical pharmacology · 2012Trial
- Bayesian estimation in NONMEM.CPT: pharmacometrics & systems pharmacology · 2024Article
- Integrated Use of In Vitro and In Vivo Information for Comprehensive Prediction of Drug Interactions Due to Inhibition of Multiple CYP Isoenzymes.Clinical pharmacokinetics · 2023Article
- A "middle-out approach" for the prediction of human drug disposition from preclinical data using simplified physiologically based pharmacokinetic (PBPK) models.CPT: pharmacometrics & systems pharmacology · 2023Article
- Investigation of simplified physiologically-based pharmacokinetic models in rat and human.CPT: pharmacometrics & systems pharmacology · 2023Article
- Pulmonary Pharmacokinetic and Pharmacodynamic Evaluation of Ampicillin/Sulbactam Regimens for Pneumonia Caused by Various Bacteria, includingAntibiotics (Basel, Switzerland) · 2023Article
- Population PBPK modeling using parametric and nonparametric methods of the Simcyp Simulator, and Bayesian samplers.CPT: pharmacometrics & systems pharmacology · 2022Article
- Proteomics-Informed Prediction of Rosuvastatin Plasma Profiles in Patients With a Wide Range of Body Weight.Clinical pharmacology and therapeutics · 2021Article
- Well-tempered MCMC simulations for population pharmacokinetic models.Journal of pharmacokinetics and pharmacodynamics · 2020Article
- Prior information for population pharmacokinetic and pharmacokinetic/pharmacodynamic analysis: overview and guidance with a focus on the NONMEM PRIOR subroutine.Journal of pharmacokinetics and pharmacodynamics · 2020Review
- Population pharmacokinetic reanalysis of a Diazepam PBPK model: a comparison of Stan and GNU MCSim.Journal of pharmacokinetics and pharmacodynamics · 2019Article
- Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.Clinical pharmacokinetics · 2019Review
- Whole body physiologically based modelling of β-blockers in the rat: events in tissues and plasma following an i.v. bolus dose.British journal of pharmacology · 2018Article
- Applying a Global Sensitivity Analysis Workflow to Improve the Computational Efficiencies in Physiologically-Based Pharmacokinetic Modeling.Frontiers in pharmacology · 2018Article
- A whole-body physiologically based pharmacokinetic (WB-PBPK) model of ciprofloxacin: a step towards predicting bacterial killing at sites of infection.Journal of pharmacokinetics and pharmacodynamics · 2017Article
- Application of a systems pharmacology model for translational prediction of hERG-mediated QTc prolongation.Pharmacology research & perspectives · 2016Article
- Development of a Novel Simplified PBPK Absorption Model to Explain the Higher Relative Bioavailability of the OROS® Formulation of Oxybutynin.The AAPS journal · 2016Article
- Incorporation of stochastic variability in mechanistic population pharmacokinetic models: handling the physiological constraints using normal transformations.Journal of pharmacokinetics and pharmacodynamics · 2015Article
- Combining the 'bottom up' and 'top down' approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data.British journal of clinical pharmacology · 2015Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of this study was to evaluate the performance of the NONMEM prior functionality compared to a full Bayesian method when applied to population physiological models using diazepam as a case study.
methodsWhole-body physiologically based pharmacokinetic (WBPBPK) models for diazepam were initially developed, tested and calibrated for rats and man using a full Bayesian analysis as implemented in WINBUGS: . The final models were implemented in NONMEM and the results from the two analyses compared in terms of parameter estimates, measures of parameter precision and run times.
resultsNONMEM population parameter estimates were in close agreement with those produced by the Bayesian analysis although there was a substantial shortening of run time for both the animal WBPBPK model (4.5 vs. 21 h) and human WBPBPK models (2 vs. 167 h). The adequacy of the model and the final parameter estimates were judged to be sufficient by the model's ability to describe individual tissue concentration-time profiles. The model provided a good overall description of the plasma concentration-time data in both rat and man with comparable parameter precision. A limited nonparametric bootstrap (n = 50) was performed to assess parameter sensitivity, bias and imprecision. No systematic bias was seen when comparing bootstrap means to final parameter estimates.
conclusionsThe ease of implementation and reductions in run time hopefully provide a further step forward in allowing the wider use of these complex and information-rich models together with clinical data in the future.
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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.