European Medicines Agency workshop on modelling in paediatric medicines

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TitleEuropean Medicines Agency workshop on modelling in paediatric medicines
Date14/04/2008 - 15/04/2008
LocationEuropean Medicines Agency, London, UK
Summary

All documents

Name Language First published Last updated
Agenda - European Medicines Agency workshop on modelling in paediatric medicines (English only) 2008-04-14  
Expectations from pharmacokinetic-pharmacodynamic modelling and simulation in the evaluation of medicinal products in children (English only) 2008-05-15  
Presentation - Expectations from pharmacokinetic-pharmacodynamic modelling and simulation in the evaluation of medicinal products in children (English only) 2008-05-13  
Presentation - Developmental pharmacokinetics/pharmacodynamics: What have we learnt? (English only) 2008-05-13  
Presentation - Introduction to population pharmacokinetic-pharmacodynamic modelling in paediatric clinical pharmacology (English only) 2008-05-13  
Presentation - Regulatory experience of paediatric data: Focusing on modelling aspects (English only) 2008-05-13  
Presentation - Dose selection in early paediatric development (English only) 2008-04-13  
Presentation - Study design and conduct efficiency evaluation via discrete event simulation: Applications in paediatric oncology (English only) 2008-04-13  
Presentation - Voriconazole paediatric dose: An example (English only) 2008-04-13  
Presentation - Drug evaluation in paediatrics using kinetic-pharmacodynamic models: Perspectives (English only) 2008-04-13  
Presentation - Sparse sampling design in population pharmacokinetic/pharmacodynamic studies (English only) 2008-04-13  
Presentation - Population pharmacokinetics and optimal design of paediatric studies for famciclovir (English only) 2008-04-14  
Presentation - Regulatory experience in application of modelling in dose selection (English only) 2008-04-14  
Presentation - Statistical modelling issues arising from pharmacokinetic/pharmacodynamic bridging in paediatrics (English only) 2008-04-14  
Presentation - Clinical trial design optimisation in paediatrics using prior knowledge combined with modelling and simulations (English only) 2008-04-14  
Presentation - Modelling and simulation in support of adaptive designs (English only) 2008-04-14  
Presentation - Leveraging prior knowledge in guiding paediatric drug development (English only) 2008-04-14  
Presentation - Introduction to physiologically based pharmacokinetics (English only) 2008-04-14  
Presentation - Mechanism-based concepts of size and maturity (English only) 2008-04-14  
Presentation - Blood-brain-barrier maturation: Implications for drug development (English only) 2008-04-14  
Presentation - Using the knowledge of biology in the prediction of clearance as the main determinant of drug exposure in paediatric populations (English only) 2008-04-14  
Presentation - Use of physiologically based pharmacokinetics in simulating drug concentrations in paediatric populations: Case studies of midazolam and gabapentin (English only) 2008-04-14  
Presentation - Physiologically based pharmacokinetic modeling with PK-Sim and MoBi in support of the paediatric investigation plan (English only) 2008-04-14  
Presentation - Alternative methods in risk assessment and kinetics in paediatric pharmacology: A common need for physiologically based pharmacokinetic modelling (English only) 2008-04-14  
Presentation - Advantages and challenges of a mechanism-based modelling approach to drug development and testing (English only) 2008-04-14  
Presentation - Modelling and simulation in paediatric drug development and regulation (English only) 2008-04-14  
Presentation - Modelling and simulation for paediatric investigation plans (PIPs): Challenges and opportunities for drug development (English only) 2008-04-14  
Presentation - Population pharmacokinetics/pharmacodynamics in paediatrics: A perspective on the way forward (English only) 2008-04-14  
Presentation - Regulatory vision of paediatric applications (English only) 2008-04-14  

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