European Medicines Agency workshop on modelling in paediatric medicines

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

Documents

Agenda - European Medicines Agency workshop on modelling in paediatric medicines

Reference Number: EMEA/533246/2007, Final

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

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

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

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

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

Presentation - Dose selection in early paediatric development

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

Presentation - Voriconazole paediatric dose: An example

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

Presentation - Sparse sampling design in population pharmacokinetic/pharmacodynamic studies

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

Presentation - Regulatory experience in application of modelling in dose selection

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

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

Presentation - Modelling and simulation in support of adaptive designs

Presentation - Leveraging prior knowledge in guiding paediatric drug development

Presentation - Introduction to physiologically based pharmacokinetics

Presentation - Mechanism-based concepts of size and maturity

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

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

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

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

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

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

Presentation - Modelling and simulation in paediatric drug development and regulation

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

Presentation - Population pharmacokinetics/pharmacodynamics in paediatrics: A perspective on the way forward

Presentation - Regulatory vision of paediatric applications