Pharmacometrics, based on advanced mathematical methods and simulation approaches, is being increasingly adopted by pharmaceutical industries in their drug development programs. This trend has been strengthened by the regulatory agencies which suggest exposure-response analysis in all new drug applications (NDA).
In this talk, I will report on the experience the team has developed in the area of biopharmaceutical research, fully supported by mathematical proof of concepts. I will illustrate with the particular project of optimal design regimen for antibiotics for which we have developed a more information loaded exposure-response formalism.
This project is in collaboration with Dr. J. Li