Proposals for model-based paediatric medicinal development within the current European Union regulatory framework
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Pharmacogenetics-based warfarin dosing in childrenModelling and simulation as research tools in paediatric drug developmentPBPK modeling and simulation in drug research and developmentTesting new drugs in naked apes and getting the dose right in their youngModeling and simulation as a tool to bridge efficacy and safety data in special populations.Integration of PKPD relationships into benefit-risk analysisClinical pharmacological studies in children: From exploratory towards confirmation driven methodology.What is the right dose for children?Characterizing variability in warfarin dose requirements in children using modelling and simulation.Bridging the gap: a review of dose investigations in paediatric investigation plansPopulation pharmacokinetics of deferiprone in healthy subjects.Physiologically based pharmacokinetic modeling: methodology, applications, and limitations with a focus on its role in pediatric drug development.The role of quantitative ADME proteomics to support construction of physiologically based pharmacokinetic models for use in small molecule drug development.Optimizing pharmacokinetic bridging studies in paediatric oncology using physiologically-based pharmacokinetic modelling: application to docetaxel.Scaling of pharmacokinetics across paediatric populations: the lack of interpolative power of allometric models.Treating disorders of the neonatal central nervous system: pharmacokinetic and pharmacodynamic considerations with a focus on antiepileptics.Adaptive trials in paediatric development: dealing with heterogeneity and uncertainty in pharmacokinetic differences in children.Optimizing drug development of anti-cancer drugs in children using modelling and simulation.Drug Development for Pediatric Populations: Regulatory Aspects.Dosing in children.Pediatric dose selection.Role of modeling and simulation in pediatric investigation plans.Role of modelling and simulation: a European regulatory perspective.Physiologically based pharmacokinetic (PBPK) modeling in children.Dosage individualization in children: integration of pharmacometrics in clinical practice.Physiologically based pharmacokinetic and pharmacodynamic modeling in cancer drug development: status, potential and gaps.Modeling and simulation in pediatric drug therapy: Application of pharmacometrics to define the right dose for children.Children in clinical trials: towards evidence-based pediatric pharmacotherapy using pharmacokinetic-pharmacodynamic modeling.Enhancing value of clinical pharmacodynamics in oncology drug development: An alliance between quantitative pharmacology and translational science.Impact of disease, drug and patient adherence on the effectiveness of antiviral therapy in pediatric HIV.Population pharmacokinetics and dosing recommendations for the use of deferiprone in children younger than 6 years.Have physiologically-based pharmacokinetic models delivered?Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice.Model-based approaches for ivabradine development in paediatric population, part II: PK and PK/PD assessment.Extrapolation of enalapril efficacy from adults to children using pharmacokinetic/pharmacodynamic modelling.Model-based assessment of dosing strategies in children for monoclonal antibodies exhibiting target-mediated drug dispositionThe Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation WorkshopEvaluation and optimisation of current milrinone prescribing for the treatment and prevention of low cardiac output syndrome in paediatric patients after open heart surgery using a physiology-based pharmacokinetic drug-disease model.Influence of covariate distribution on the predictive performance of pharmacokinetic models in paediatric research.Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants.
P2860
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P2860
Proposals for model-based paediatric medicinal development within the current European Union regulatory framework
description
2009 nî lūn-bûn
@nan
2009 թուականի Հոկտեմբերին հրատարակուած գիտական յօդուած
@hyw
2009 թվականի հոտեմբերին հրատարակված գիտական հոդված
@hy
2009年の論文
@ja
2009年論文
@yue
2009年論文
@zh-hant
2009年論文
@zh-hk
2009年論文
@zh-mo
2009年論文
@zh-tw
2009年论文
@wuu
name
Proposals for model-based paed ...... ean Union regulatory framework
@ast
Proposals for model-based paed ...... ean Union regulatory framework
@en
Proposals for model-based paed ...... ean Union regulatory framework
@nl
type
label
Proposals for model-based paed ...... ean Union regulatory framework
@ast
Proposals for model-based paed ...... ean Union regulatory framework
@en
Proposals for model-based paed ...... ean Union regulatory framework
@nl
prefLabel
Proposals for model-based paed ...... ean Union regulatory framework
@ast
Proposals for model-based paed ...... ean Union regulatory framework
@en
Proposals for model-based paed ...... ean Union regulatory framework
@nl
P2860
P3181
P1476
Proposals for model-based paed ...... ean Union regulatory framework
@en
P2093
Efthymios Manolis
Gérard Pons
P2860
P304
P3181
P356
10.1111/J.1365-2125.2009.03484.X
P407
P577
2009-10-01T00:00:00Z