Leiden Workshop: May 2018

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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