Role of modelling and simulation in Phase I drug development.
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Modelling and simulation as research tools in paediatric drug developmentClinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-Patient Study Designs in Psoriasis.Biomarkers in drug discovery and development: from target identification through drug marketing.Safety and efficacy: the role of chemistry, manufacturing, and controls in pharmaceutical drug development.Pharmacokinetic/pharmacodynamic modelling in oncological drug development.Generating Virtual Patients by Multivariate and Discrete Re-Sampling TechniquesPopulation pharmacokinetics of oseltamivir in non-pregnant and pregnant women.Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? A survey of the literature from 2002 to 2004.Development of translational pharmacokinetic-pharmacodynamic modelsA survey of the way pharmacokinetics are reported in published phase I clinical trials, with an emphasis on oncology.Clinical trial simulation: a review.Role of modelling and simulation: a European regulatory perspective.Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014)A semi-mechanistic model to characterize the pharmacokinetics and pharmacodynamics of brodalumab in healthy volunteers and subjects with psoriasis in a first-in-human single ascending dose study.Prediction discrepancies for the evaluation of nonlinear mixed-effects models.Pharmacometric Analyses to Support Early Development Decisions for LY2878735: A Novel Serotonin Norepinephrine Reuptake Inhibitor.Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide.Model-based decision making in early clinical development: minimizing the impact of a blood pressure adverse event.A new exact test for the evaluation of population pharmacokinetic and/or pharmacodynamic models using random projections.A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A.Population pharmacokinetic and pharmacodynamic analysis in allergic diseases.A general model-based design of experiments approach to achieve practical identifiability of pharmacokinetic and pharmacodynamic models.Bridging the efficacy–effectiveness gap: a regulator's perspective on addressing variability of drug responseBenefits of Model-based Drug Development: A Rigorous, Planned Case Study
P2860
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P2860
Role of modelling and simulation in Phase I drug development.
description
2001 nî lūn-bûn
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2001 թուականի Մայիսին հրատարակուած գիտական յօդուած
@hyw
2001 թվականի մայիսին հրատարակված գիտական հոդված
@hy
2001年の論文
@ja
2001年論文
@yue
2001年論文
@zh-hant
2001年論文
@zh-hk
2001年論文
@zh-mo
2001年論文
@zh-tw
2001年论文
@wuu
name
Role of modelling and simulation in Phase I drug development.
@ast
Role of modelling and simulation in Phase I drug development.
@en
Role of modelling and simulation in Phase I drug development.
@nl
type
label
Role of modelling and simulation in Phase I drug development.
@ast
Role of modelling and simulation in Phase I drug development.
@en
Role of modelling and simulation in Phase I drug development.
@nl
prefLabel
Role of modelling and simulation in Phase I drug development.
@ast
Role of modelling and simulation in Phase I drug development.
@en
Role of modelling and simulation in Phase I drug development.
@nl
P2093
P1476
Role of modelling and simulation in Phase I drug development.
@en
P2093
A van Peer
COST B15 Experts
J L Steimer
M O Karlsson
P304
P356
10.1016/S0928-0987(01)00096-3
P407
P577
2001-05-01T00:00:00Z