Peer-Reviewed Publication
J Clin Pharmacol2026;66(9):e70289.September 1, 2026Journal Article
Quantitative Systems Pharmacology (QSP): Bridging Biology and Mechanism with Clinical Drug Development Decisions.
Weirong Wang1, Alexander V Ratushny2, Steve Chang3, Yougan Cheng4, Jingqi Q X Gong5, Abhishek Gulati6, Emma Hansson7, Alexander Kulesza8, Federico Reali9, Conner Sandefur3, Brian J Schmidt10, Fulya Akpinar Singh11, Monica E Susilo12, Susana Zaph13, Blerta Shtylla14
1Johnson & Johnson, Spring House, PA, USA.
2Bristol Myers Squibb, Seattle, WA, USA.
3Simulations Plus, Inc., Research Triangle Park, NC, USA.
4Daiichi Sankyo Inc., Basking Ridge, NJ, USA.
5GlaxoSmithKline, Collegeville, PA, USA.
6Merck & Co., Inc., West Point, PA, USA.
7Pharmetheus AB, Uppsala, Sweden.
8ESQlabs GmbH, Saterland, Germany.
9Fondazione The Microsoft Research - University of Trento Center for Computational and Systems Biology, Rovereto, Italy.
10Madrigal Pharmaceuticals, West Conshohocken, PA, USA.
11Genmab US, Princeton, NJ, USA.
12Genentech, Inc., South San Francisco, CA, USA.
13Sanofi, Morristown, NJ, USA.
14Pfizer Inc., San Diego, CA, USA.
Abstract
Quantitative systems pharmacology (QSP) integrates mechanistic representations of biology with quantitative pharmacology to support decision‑making across the drug development continuum. Over the past two decades, QSP has evolved from an exploratory research activity into an established component of model‑informed drug development (MIDD), particularly in settings where system‑level interactions co…
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