As the transition to model-based drug development continues, pharmacometric analysis will have an increasingly important role across the entire life cycle of drug discovery, development, regulatory approval, and commercialization. For this reason, pharmacometrics can–and should–have an integrating function in the transformation to model-based development. This essay describes an approach for formalizing the pharmacometrics process using the disciplines encompassed by enterprise engineering.

By, Thaddeus H Grasela, Dement CW, Kolterman OG, Fineman MS, Grasela DM, Honig P, Antal EJ, Bjornsson TD, Loh E