Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
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Top-down, Bottom-up and Middle-out Strategies for Drug Cardiac Safety Assessment via Modeling and SimulationsRecent developments in using mechanistic cardiac modelling for drug safety evaluationThe promises of quantitative systems pharmacology modelling for drug developmentCPT: Pharmacometrics and Systems PharmacologyBasic Concepts in Population Modeling, Simulation, and Model-Based Drug DevelopmentWhite paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simulation.Pharmacokinetic/pharmacodynamic modelling approaches in paediatric infectious diseases and immunologyResponse-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects.Boceprevir dosing for late responders and null responders: the role of bridging data between treatment-naïve and -experienced subjects.The evolution of the regulatory framework for antibacterial agentsPredictive Performance of a Vancomycin Population Pharmacokinetic Model in NeonatesPharmacometric Models for Characterizing the Pharmacokinetics of Orally Inhaled Drugs.Effect of Kidney Function on Drug Kinetics and Dosing in Neonates, Infants, and ChildrenPharmacokinetics of tralokinumab in adolescents with asthma: implications for future dosing.Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and DocumentationCommunicating to Influence Drug Development and Regulatory Decisions: A Tutorial.Improper selection of a pre-specified primary dose-response analysis delays regulatory drug approvalApplications of pharmacometrics in the clinical development and pharmacotherapy of anti-infectives.A four-compartment PBPK heart model accounting for cardiac metabolism - model development and application.Personalized medicine policy challenges: measuring clinical utility at point of care.Personalizing oncology treatments by predicting drug efficacy, side-effects, and improved therapy: mathematics, statistics, and their integration.Mathematical modeling and simulation in animal health. Part I: Moving beyond pharmacokinetics.Exposure-Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies.Pharmacotherapy in pediatric epilepsy: from trial and error to rational drug and dose selection - a long way to go.A proposal for scientific framework enabling specific population drug dosing recommendations.Catalyzing the Critical Path Initiative: FDA's progress in drug development activities.Modeling and simulation in clinical pharmacology and dose findingEstablishing Good Practices for Exposure-Response Analysis of Clinical Endpoints in Drug Development.Pharmacometric Analyses to Support Early Development Decisions for LY2878735: A Novel Serotonin Norepinephrine Reuptake Inhibitor.Regulatory modeling and simulation moves into the next gear in europe.Humans Vary, So Cardiac Models Should Account for That Too!Use of a biomarker in exposure-response analysis to support dose selection for fingolimod.Establishing best practices and guidance in population modeling: an experience with an internal population pharmacokinetic analysis guidance.Integration of biostatistics and pharmacometrics computing platforms for efficient and reproducible PK/PD analysis: a case study.Pharmacokinetic modeling and simulation of biweekly subcutaneous immunoglobulin dosing in primary immunodeficiency.An automated sampling importance resampling procedure for estimating parameter uncertainty.Pharmacometrics for regulatory decision making: status and perspective.Phenobarbital in intensive care unit pediatric population: predictive performances of population pharmacokinetic model.Precision Dosing: Public Health Need, Proposed Framework, and Anticipated Impact.Use of statistical and pharmacokinetic-pharmacodynamic modeling and simulation to improve decision-making: A section summary report of the trends and innovations in clinical trial statistics conference.
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P2860
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
description
article científic
@ca
article scientifique
@fr
articol științific
@ro
articolo scientifico
@it
artigo científico
@gl
artigo científico
@pt
artigo científico
@pt-br
artikel ilmiah
@id
artikull shkencor
@sq
artículo científico
@es
name
Impact of pharmacometric analy ...... issions between 2000 and 2008.
@en
Impact of pharmacometric analy ...... issions between 2000 and 2008.
@nl
type
label
Impact of pharmacometric analy ...... issions between 2000 and 2008.
@en
Impact of pharmacometric analy ...... issions between 2000 and 2008.
@nl
prefLabel
Impact of pharmacometric analy ...... issions between 2000 and 2008.
@en
Impact of pharmacometric analy ...... issions between 2000 and 2008.
@nl
P2093
P2860
P1476
Impact of pharmacometric analy ...... missions between 2000 and 2008
@en
P2093
Anshu Marathe
Christoffer Tornoe
Jogarao V S Gobburu
Joo Yeon Lee
Justin C Earp
Kevin Krudys
Lawrence J Lesko
P2860
P304
P356
10.2165/11593210-000000000-00000
P577
2011-10-01T00:00:00Z
P6179
1004201759