This second 3-day course will introduce participants to basic principles in the pharmacokinetics and pharmacodynamics of novel therapeutic proteins and provide opportunities for basic hands-on exercises in the PK/PD evaluation of these compounds. Topics include target-mediated drug disposition, tissue and tumor penetration, first-in-human dose selection, immunogenicity, clinical pharmacology challenges, biosimilars, and drug-drug interactions. Hands-on exercises and simulations will be performed individually and in small groups using simple software tools (no prior experience required).
The course is a shortened version of the week-long course on ‘Pharmacokinetics and Pharmacodynamics of Protein Therapeutics – Concepts and Hands-On Modeling and Simulation’ that Drs. Meibohm and Gabrielsson have offered for the last seven years in the United States. Christian will co-host this course together with Pascal Girard and Maike Puetter from Merck.