Abstract
To demonstrate the usefulness of the techniques used in PK/PD analysis as well as Modeling and Simulation with clinical data (pharmacometrics), the following 3 examples are described: 1) modeling based on the data from healthy volunteers administered erythropoietin, and simulation to predict both route/dosage/effect relationship and maintenance dose distribution in renal anemia patients; 2) simultaneous population PK/PD analysis of the anti-IgE antibody drug, omalizumab, using plasma concentrations of the drug, free IgE and drug-IgE complex, and model validation using simulation; 3) population PK and PK/PD analyses of sildenafil using peak oxygen consumption in pediatric patients with pulmonary arterial hypertension, and simulation using both models to predict the optimal dosage in pediatric patient population. In addition, the background and current situation of pharmacometrics in overseas countries are introduced.
