Role of modelling and simulation: a European regulatory perspective. - Wikidata - awgldk - TriplyDB

Role of modelling and simulation: a European regulatory perspective.

Role of modelling and simulation: a European regulatory perspective.

http://www.wikidata.org/entity/Q37976876

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Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation Applications of pharmacometrics in the clinical development and pharmacotherapy of anti-infectives.Translational Modeling and Simulation in Supporting Early-Phase Clinical Development of New Drug: A Learn-Research-Confirm Process.From preclinical to human--prediction of oral absorption and drug-drug interaction potential using physiologically based pharmacokinetic (PBPK) modeling approach in an industrial setting: a workflow by using case example.Dose-finding methods for Phase I clinical trials using pharmacokinetics in small populations.Modeling and simulation in clinical pharmacology and dose finding Influence of covariate distribution on the predictive performance of pharmacokinetic models in paediatric research.

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P2860

Role of modelling and simulation: a European regulatory perspective.

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Role of modelling and simulation: a European regulatory perspective.

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Role of modelling and simulation: a European regulatory perspective.

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Role of modelling and simulation: a European regulatory perspective.

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Role of modelling and simulation: a European regulatory perspective.

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Clinical Pharmacokinetics

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Role of modelling and simulation: a European regulatory perspective

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Anja Henningsson

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Monica Edholm

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Tomas Salmonson

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P2860

Proposals for model-based paediatric medicinal development within the current European Union regulatory framework

Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: concepts and perspectives.

Clinical trial simulation in drug development.

Pharmacokinetic/pharmacodynamic modeling in drug development.

Simulation of clinical trials.

Modelling during drug development.

Impact of population pharmacokinetic-pharmacodynamic analyses on the drug development process: experience at Parke-Davis.

Role of modelling and simulation in Phase I drug development.

Pharmacokinetic/pharmacodynamic studies in drug product development.

Model-based drug development: the road to quantitative pharmacology.

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