How Has Modeling and Simulation Influenced Label Claims in Drug Development

Speaker:

Peter Bonate, Executive Director, Clinical Pharmacology & Exploratory Development
PKMS New Technologies- Astellas Pharma US

Description:

One of the central questions in developing new drugs is the dose.
Do you have the right dose? Does it maximize benefit and minimize
risk? Pharmacokinetic-pharmacodynamic modeling and simulation, which
establishes the relationship between dose, drug concentrations, and
effect, is increasingly being used to address this question. This
seminar will present examples of how modeling and simulation is used in
drug development and how they influence regulatory label claims.