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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...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BlackWell Publishing Ltd
2015
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4394612/ https://www.ncbi.nlm.nih.gov/pubmed/26225239 http://dx.doi.org/10.1002/psp4.20 |