European Medicines Agency workshop on modelling in paediatric medicines

Date: Monday, 14 April 2008, All day
Location: European Medicines Agency, Amsterdam, the Netherlands

Documents

Agenda - European Medicines Agency workshop on modelling in paediatric medicines

Reference Number: EMEA/533246/2007, Final

English (EN) (62.74 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

Expectations from pharmacokinetic-pharmacodynamic modelling and simulation in the evaluation of medicinal products in children

English (EN) (78.74 KB - PDF)

Først publisert: 15/05/2008 Sist oppdatert: 15/05/2008

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Presentation - Expectations from pharmacokinetic-pharmacodynamic modelling and simulation in the evaluation of medicinal products in children

English (EN) (25.09 KB - PDF)

Først publisert: 13/05/2008 Sist oppdatert: 13/05/2008

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Presentation - Developmental pharmacokinetics/pharmacodynamics: What have we learnt?

English (EN) (1.49 MB - PDF)

Først publisert: 13/05/2008 Sist oppdatert: 13/05/2008

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Presentation - Introduction to population pharmacokinetic-pharmacodynamic modelling in paediatric clinical pharmacology

English (EN) (1.11 MB - PDF)

Først publisert: 13/05/2008 Sist oppdatert: 13/05/2008

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Presentation - Regulatory experience of paediatric data: Focusing on modelling aspects

English (EN) (339.12 KB - PDF)

Først publisert: 13/05/2008 Sist oppdatert: 13/05/2008

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Presentation - Dose selection in early paediatric development

English (EN) (762.34 KB - PDF)

Først publisert: 13/04/2008 Sist oppdatert: 13/04/2008

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Presentation - Study design and conduct efficiency evaluation via discrete event simulation: Applications in paediatric oncology

English (EN) (925.79 KB - PDF)

Først publisert: 13/04/2008 Sist oppdatert: 13/04/2008

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Presentation - Voriconazole paediatric dose: An example

English (EN) (280.57 KB - PDF)

Først publisert: 13/04/2008 Sist oppdatert: 13/04/2008

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Presentation - Drug evaluation in paediatrics using kinetic-pharmacodynamic models: Perspectives

English (EN) (439.87 KB - PDF)

Først publisert: 13/04/2008 Sist oppdatert: 13/04/2008

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Presentation - Sparse sampling design in population pharmacokinetic/pharmacodynamic studies

English (EN) (156.47 KB - PDF)

Først publisert: 13/04/2008 Sist oppdatert: 13/04/2008

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Presentation - Population pharmacokinetics and optimal design of paediatric studies for famciclovir

English (EN) (783.16 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Regulatory experience in application of modelling in dose selection

English (EN) (79.77 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Statistical modelling issues arising from pharmacokinetic/pharmacodynamic bridging in paediatrics

English (EN) (290.45 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Clinical trial design optimisation in paediatrics using prior knowledge combined with modelling and simulations

English (EN) (3.15 MB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Modelling and simulation in support of adaptive designs

English (EN) (184.67 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Leveraging prior knowledge in guiding paediatric drug development

English (EN) (809.99 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Introduction to physiologically based pharmacokinetics

English (EN) (427.57 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Mechanism-based concepts of size and maturity

English (EN) (667.42 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Blood-brain-barrier maturation: Implications for drug development

English (EN) (119.38 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Using the knowledge of biology in the prediction of clearance as the main determinant of drug exposure in paediatric populations

English (EN) (1.27 MB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Use of physiologically based pharmacokinetics in simulating drug concentrations in paediatric populations: Case studies of midazolam and gabapentin

English (EN) (378.33 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Physiologically based pharmacokinetic modeling with PK-Sim and MoBi in support of the paediatric investigation plan

English (EN) (917.29 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Alternative methods in risk assessment and kinetics in paediatric pharmacology: A common need for physiologically based pharmacokinetic modelling

English (EN) (689.46 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Advantages and challenges of a mechanism-based modelling approach to drug development and testing

English (EN) (1.85 MB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Modelling and simulation in paediatric drug development and regulation

English (EN) (233.49 KB - PDF)

Først publisert: 14/04/2008 Sist oppdatert: 14/04/2008

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Presentation - Modelling and simulation for paediatric investigation plans (PIPs): Challenges and opportunities for drug development