FDA Advisory Meeting Clinical Pharmacology Review Utilizes a Quantitative Systems Pharmacology (QSP) Model: A Watershed Moment?

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 applic...

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Bibliographic Details
Main Authors: Peterson, MC, Riggs, MM
Format: Online
Language:English
Published: BlackWell Publishing Ltd 2015
Online Access:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4394612/