Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials.
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Recent Advances in Development and Application of Physiologically-Based Pharmacokinetic (PBPK) Models: a Transition from Academic Curiosity to Regulatory AcceptanceRational use of medicine in the pediatric age group: A summary on the role of clinical pharmacistsStrategic biomarkers for drug development in treating rare diseases and diseases in neonates and infantsPhysiologically Based Pharmacokinetic Predictions of Tramadol Exposure Throughout Pediatric Life: an Analysis of the Different Clearance Contributors with Emphasis on CYP2D6 Maturation.PBPK modeling and simulation in drug research and developmentPhysiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model VerificationA re-evaluation and validation of ontogeny functions for cytochrome P450 1A2 and 3A4 based on in vivo data.How Does In Vivo Biliary Elimination of Drugs Change with Age? Evidence from In Vitro and Clinical Data Using a Systems Pharmacology Approach.Concomitant use of tamoxifen and endoxifen in postmenopausal early breast cancer: prediction of plasma levels by physiologically-based pharmacokinetic modeling.Physiologically based pharmacokinetic modeling and simulation in pediatric drug developmentThe role of quantitative ADME proteomics to support construction of physiologically based pharmacokinetic models for use in small molecule drug development.Human Ontogeny of Drug Transporters: Review and Recommendations of the Pediatric Transporter Working GroupObservational infant exploratory [(14)C]-paracetamol pharmacokinetic microdose/therapeutic dose study with accelerator mass spectrometry bioanalysis.Optimizing pharmacokinetic bridging studies in paediatric oncology using physiologically-based pharmacokinetic modelling: application to docetaxel.Development of a Pediatric Physiologically-Based Pharmacokinetic Model of Clindamycin Using Opportunistic Pharmacokinetic Data.Effect of Kidney Function on Drug Kinetics and Dosing in Neonates, Infants, and ChildrenNatural Language Processing for EHR-Based Pharmacovigilance: A Structured Review.Pharmacokinetic studies in infants using minimal-risk study designsA workflow example of PBPK modeling to support pediatric research and development: case study with lorazepamOptimizing drug development of anti-cancer drugs in children using modelling and simulation.Characterizing the Developmental Trajectory of Sirolimus Clearance in Neonates and InfantsApplication of physiologically based pharmacokinetic modeling in predicting drug-drug interactions for sarpogrelate hydrochloride in humansApplication of physiologically based pharmacokinetic modeling to predict acetaminophen metabolism and pharmacokinetics in childrenPredictive Performance of Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling of Renally Cleared Drugs in Children.Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.Physiologically based pharmacokinetics joined with in vitro-in vivo extrapolation of ADME: a marriage under the arch of systems pharmacology.Developmental changes in the expression and function of cytochrome P450 3A isoforms: evidence from in vitro and in vivo investigations.Do children have the same vulnerability to metabolic drug–drug interactions as adults? A critical analysis of the literature.Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective.Challenges and considerations for development of therapeutic proteins in pediatric patients.Prediction of drug clearance in children: a review of different methodologies.Modeling and simulation in pediatric drug therapy: Application of pharmacometrics to define the right dose for children.In Silico Dose Prediction for Long-Acting Rilpivirine and Cabotegravir Administration to Children and Adolescents.Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.Predicting nonlinear pharmacokinetics of omeprazole enantiomers and racemic drug using physiologically based pharmacokinetic modeling and simulation: application to predict drug/genetic interactions.Examining Small Intestinal Transit Time as a Function of Age: Is There Evidence to Support Age-Dependent Differences among Children?Meta-analysis of hepatic cytochrome P450 ontogeny to underwrite the prediction of pediatric pharmacokinetics using physiologically based pharmacokinetic modeling.Applied Concepts in PBPK Modeling: How to Build a PBPK/PD Model.Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.Whole body physiologically based modelling of beta-blockers in the rat: Events in tissues and plasma following an intravenous bolus dose.
P2860
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P2860
Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials.
description
2012 nî lūn-bûn
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2012年の論文
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2012年学术文章
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2012年学术文章
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2012年学术文章
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2012年学术文章
@zh-hans
2012年学术文章
@zh-my
2012年学术文章
@zh-sg
2012年學術文章
@yue
2012年學術文章
@zh-hant
name
Regulatory experience with phy ...... ing for pediatric drug trials.
@en
Regulatory experience with phy ...... ing for pediatric drug trials.
@nl
type
label
Regulatory experience with phy ...... ing for pediatric drug trials.
@en
Regulatory experience with phy ...... ing for pediatric drug trials.
@nl
prefLabel
Regulatory experience with phy ...... ing for pediatric drug trials.
@en
Regulatory experience with phy ...... ing for pediatric drug trials.
@nl
P2093
P2860
P356
P1476
Regulatory experience with phy ...... ing for pediatric drug trials.
@en
P2093
G J Burckart
M L T Vieira
Y Mulugeta
P2860
P2888
P304
P356
10.1038/CLPT.2012.19
P407
P577
2012-05-01T00:00:00Z
P6179
1016986181