Model-informed Drug Development

Incorporating population variability into mechanistic prediction of PK and modeling PK/PD

May 14–18 in Leiden, The Netherlands

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 (pediatrics, ethnic groups, various disease populations)
• Data for therapeutic proteins
• 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)

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