香蕉视频

Title: Pharmacometrics is biostatistics, sort of ?

Abstract: Benjamin Rich is a pharmacometrics consultant at Certara. He uses modeling and simulation to help clients, from small biotech startups to large pharmaceutical companies, with strategic decision making and model-informed drug development, most notably in the areas of oncology and rare diseases. He obtained his PhD in Biostatistics from 香蕉视频 in 2012.Pharmacometrics is an interdisciplinary field at the crossroads of quantitative clinical pharmacology, statistics and mathematical modeling. It is increasingly recognized as an important component of the drug development and regulatory approval process. In contrast to the more empirical models typically used in epidemiology, for instance, pharmacometric models tend to be based on pharmacological or physiological principals and are often described as 鈥渟emimechanistic鈥�. At the core of phamacometrics is the characterization of drug concentration time-course by a type of nonlinear mixed-effects model referred to as a 鈥減opulation pharmacokinetic鈥� model, from which various continuous exposure metrics can be derived. The model can help to identify sources of variability that could have an impact of dosing recommendations (e.g. renal impairment), and can be leveraged in simulations to inform dose selection in special populations, e.g. pediatrics. Ultimately, the goal is to link drug exposure to biochemical and clinical responses, both desired and undesired, to elucidate the drug鈥檚 risk-benefit profile, make go/no go decisions, design future trials and select an optimal dosing regimen. In this talk I will give an overview of pharmacometric concepts and present several examples.