title: FDA Advisory Meeting Clinical Pharmacology Review Utilizes a Quantitative Systems Pharmacology (QSP) Model: A Watershed Moment?
abstract: In the evolving discipline of quantitative systems pharmacology (QSP), QSP model (QSPM) applications are expanding. Recently, a QSPM was used by US Food and Drug Administration (FDA) clinical pharmacologists to evaluate the appropriateness of a proposed dosing regimen for a new biologic. This application expands the use-horizon for QSPMs into the regulatory domain. Here we retrace the evolution of the model and suggest a question-based approach to directing model scope, identifying applications, and understanding overall QSPM value.
authors.affiliation: Global Clinical Pharmacology, Pfizer Inc. Cambridge, Massachusetts, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Peterson
authors.affiliation: Metrum Research Group Tariffville, Connecticut, USA.
authors.forename: M M
authors.initials: MM
authors.lastname: Riggs