QUESTIONS‘Model-based drug development: Incorporating population variability into mechanistic prediction of
Venue: Ramada Plaza
Location: Basel, Switzerland
| Event Date/Time: Apr 16, 2012 | End Date/Time: Apr 20, 2012 |
| Registration Date: Mar 16, 2012 | |
| Early Registration Date: Jan 16, 2012 |
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The workshops combine lectures, delivered by leading experts in each field of ADME, with interactive workshops centred on practical examples demonstrating how in vitro data generated during drug development can be used to predict:
• 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)
The model-based approach is rapidly being adopted by industry to streamline drug development. These workshops focus on the optimal use of in vitro, in vivo and compound-specific data to simulate and understand drug behaviour in various target populations. This integrated approach informs decisions on the conduct and optimal design of clinical studies with the ultimate aim of improving the quality of submissions for regulatory approval.
• 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)
The model-based approach is rapidly being adopted by industry to streamline drug development. These workshops focus on the optimal use of in vitro, in vivo and compound-specific data to simulate and understand drug behaviour in various target populations. This integrated approach informs decisions on the conduct and optimal design of clinical studies with the ultimate aim of improving the quality of submissions for regulatory approval.
