The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
about
Modeling and simulation at the interface of nonclinical and early clinical drug developmentModeling and simulation as a tool to bridge efficacy and safety data in special populations.Implementation of quantitative and systems pharmacology in large pharma.Pharmacometric Models for Characterizing the Pharmacokinetics of Orally Inhaled Drugs.Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claimsGood Practices in Model-Informed Drug Discovery and Development: Practice, Application, and DocumentationA New Paradigm. "Learn - Learn More"; Dose-Exposure-Response at the Center of Drug Development and Regulatory Approval.Modeling and simulation in clinical pharmacology and dose findingRegulatory modeling and simulation moves into the next gear in europe.Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective.Establishing best practices and guidance in population modeling: an experience with an internal population pharmacokinetic analysis guidance.Mathematical modeling of efficacy and safety for anticancer drugs clinical development.Preclinical QSP Modeling in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape.In silico clinical trials for pediatric orphan diseases.Drugs Being Eliminated via the Same Pathway Will Not Always Require Similar Pediatric Dose Adjustments.Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.Adaptive paediatric investigation plans, a small step to improve regulatory decision making in drug development for children?Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency.
P2860
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P2860
The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
description
2013 nî lūn-bûn
@nan
2013年の論文
@ja
2013年論文
@yue
2013年論文
@zh-hant
2013年論文
@zh-hk
2013年論文
@zh-mo
2013年論文
@zh-tw
2013年论文
@wuu
2013年论文
@zh
2013年论文
@zh-cn
name
The Role of Modeling and Simul ...... deling and Simulation Workshop
@en
type
label
The Role of Modeling and Simul ...... deling and Simulation Workshop
@en
prefLabel
The Role of Modeling and Simul ...... deling and Simulation Workshop
@en
P2093
P2860
P356
P1476
The Role of Modeling and Simul ...... deling and Simulation Workshop
@en
P2093
M Karlsson
P A Milligan
R Hemmings
T Salmonson
P2860
P356
10.1038/PSP.2013.7
P577
2013-02-27T00:00:00Z