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
English (EN) (62.74 KB - PDF)
Expectations from pharmacokinetic-pharmacodynamic modelling and simulation in the evaluation of medicinal products in children
English (EN) (78.74 KB - PDF)
Presentation - Expectations from pharmacokinetic-pharmacodynamic modelling and simulation in the evaluation of medicinal products in children
English (EN) (25.09 KB - PDF)
Presentation - Developmental pharmacokinetics/pharmacodynamics: What have we learnt?
English (EN) (1.49 MB - PDF)
Presentation - Introduction to population pharmacokinetic-pharmacodynamic modelling in paediatric clinical pharmacology
English (EN) (1.11 MB - PDF)
Presentation - Regulatory experience of paediatric data: Focusing on modelling aspects
English (EN) (339.12 KB - PDF)
Presentation - Dose selection in early paediatric development
English (EN) (762.34 KB - PDF)
Presentation - Study design and conduct efficiency evaluation via discrete event simulation: Applications in paediatric oncology
English (EN) (925.79 KB - PDF)
Presentation - Voriconazole paediatric dose: An example
English (EN) (280.57 KB - PDF)
Presentation - Drug evaluation in paediatrics using kinetic-pharmacodynamic models: Perspectives
English (EN) (439.87 KB - PDF)
Presentation - Sparse sampling design in population pharmacokinetic/pharmacodynamic studies
English (EN) (156.47 KB - PDF)
Presentation - Population pharmacokinetics and optimal design of paediatric studies for famciclovir
English (EN) (783.16 KB - PDF)
Presentation - Regulatory experience in application of modelling in dose selection
English (EN) (79.77 KB - PDF)
Presentation - Statistical modelling issues arising from pharmacokinetic/pharmacodynamic bridging in paediatrics
English (EN) (290.45 KB - PDF)
Presentation - Clinical trial design optimisation in paediatrics using prior knowledge combined with modelling and simulations
English (EN) (3.15 MB - PDF)
Presentation - Modelling and simulation in support of adaptive designs
English (EN) (184.67 KB - PDF)
Presentation - Leveraging prior knowledge in guiding paediatric drug development
English (EN) (809.99 KB - PDF)
Presentation - Introduction to physiologically based pharmacokinetics
English (EN) (427.57 KB - PDF)
Presentation - Mechanism-based concepts of size and maturity
English (EN) (667.42 KB - PDF)
Presentation - Blood-brain-barrier maturation: Implications for drug development
English (EN) (119.38 KB - PDF)
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)
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)
Presentation - Physiologically based pharmacokinetic modeling with PK-Sim and MoBi in support of the paediatric investigation plan
English (EN) (917.29 KB - PDF)
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)
Presentation - Advantages and challenges of a mechanism-based modelling approach to drug development and testing
English (EN) (1.85 MB - PDF)
Presentation - Modelling and simulation in paediatric drug development and regulation
English (EN) (233.49 KB - PDF)
Presentation - Modelling and simulation for paediatric investigation plans (PIPs): Challenges and opportunities for drug development
English (EN) (611.32 KB - PDF)
Presentation - Population pharmacokinetics/pharmacodynamics in paediatrics: A perspective on the way forward
English (EN) (848 KB - PDF)
Presentation - Regulatory vision of paediatric applications
English (EN) (245.77 KB - PDF)