Intensive workshops on Model-based drug development: Incorporating population variability into mecha (SimcypWKS)

Venue: Red Lion Hotel Fifth Avenue

Location: Red Lion Hotel on Fifth Avenue, 1415 Fifth Avenue,, United States

Event Date/Time: Oct 29, 2012 End Date/Time: Nov 02, 2012
Report as Spam

Description

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

Additional Information

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)

Types