Intensive course on Model-based drug development: Incorporating population variability into mechanis (SimcypWKS)

Venue: Principal Hayley - Kenwood Hall

Location: Sheffield, United Kingdom

Event Date/Time: Sep 10, 2012 End Date/Time: Sep 14, 2012
Registration Date: Aug 10, 2012
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Description

The model-based approach to various aspects of
drug development is rapidly being adopted by
the leading pharmaceutical companies.
The Simcyp workshops focus on the optimal
use of compound-specific in vitro and in vivo
data together with system specific information
related to humans to simulate and understand
drug behaviour in various target populations.
This integrated approach informs decisions
related to Investigational New Drugs and assists
with the conduct and optimal design of clinical
studies. The ultimate aim is to improve the
quality of submissions for regulatory approval.

Delegates will learn how to simulate:
• Metabolic drug clearance (CL)
• Metabolic drug-drug interactions (DDIs)
• Gut first-pass metabolism
• Oral drug absorption incorporating food effects and the impact of dosage form
• Effect of transporters and enterohepatic recirculation on kinetics and DDIs
• Drug distribution to different organs
• Population variability in drug concentration-time profiles
• Variation in kinetics in specific populations (paediatrics, ethnic groups, various disease populations)
• Pharmacodynamic effects of different compounds
• Time-course of drug in plasma that fits observed clinical data (achieved by combining fitting techniques with IVIVE, PBPK and drug specific in vitro data)

Venue

Kenwood Road, Sheffield, England, S7 1NQ
Sheffield
United Kingdom
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