Ponente
Descripción
Abstract
Introduction: Pharmacometry is a vibrant scientific discipline that is shaped by the cycle of excellence: integration, innovation and impact. Objective: To evaluate different pharmacokinetic parameters of the Cuban biotechnological product Nimotuzumab. Methods: A population pharmacokinetic analysis of nimotuzumab was performed in patients with breast cancer, polycystic kidney cancer, pancreatic cancer, and solid tumors. Fixed effects modeling in RevMan 5.0.20 and the ForestPlot figure were used for data analysis. Results: The best model obtained for nimotuzumab was the quasi-steady-state approximation of the full receptor-mediated disposition model. This model allowed to describe the linear and non-linear kinetic behavior of the monoclonal antibody. Conclusions: The optimal recommended biological dose was 200 mg weekly. Modeling with a population approach, due to its integrating and predictive nature, was very useful in the optimal characterization of the PK and PD properties of this Cuban biotechnological product. In addition, it has a notable impact on the pharmaceutical industry in saving money and time, as well as, in the regulatory field, in decision-making during the process of research, development and subsequent marketing of new products.
Keywords: pharmacometry, pharmacokinetics, pharmacodynamics, nimotuzumab, meta-analysis.
