Application of pharmacometrics in drug development

Abstract

The last two decades have witnessed profound changes in how advanced computational tools can help leverage tons of data to improve our knowledge, and ultimately reduce cost and increase productivity in drug development. Pharmacometrics has demonstrated its impact through model-informed drug development (MIDD) approaches. It is now an indispensable component throughout the whole continuum of drug discovery, development, regulatory review, and approval. Today, applications of pharmacometrics are common in designing better trials and accelerating evidence-based decisions. Newly emerging technologies, especially those from data and computer sciences, are being integrated with existing computational tools used in the pharmaceutical industry at a remarkably fast pace. The new challenges faced by the pharmacometrics community are not what or how to contribute, but which optimal MIDD strategy should be adopted to maximize its value in the decision-making process. While we are embracing new innovative approaches and tools, this article discusses how a variety of existing modeling tools, with differentiated advantages and focus, can work in concert to inform drug development.