ArticleCPT: pharmacometrics & systems pharmacology2015
FDA Advisory Meeting Clinical Pharmacology Review Utilizes a Quantitative Systems Pharmacology (QSP) Model: A Watershed Moment?
Article in CPT: pharmacometrics & systems pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
53 citing papers in PubMed.
- Teclistamab Dosing in Responders: Modeling and Simulation Results from the MajesTEC-1 Study in Relapsed/Refractory Multiple Myeloma.Targeted oncology · 2025Trial
- Disease Systems Analysis of Bone Mineral Density and Bone Turnover Markers in Response to Alendronate, Placebo, and Washout in Postmenopausal Women.CPT: pharmacometrics & systems pharmacology · 2016Trial
- Quantitative Systems Pharmacology (QSP): Bridging Biology and Mechanism with Clinical Drug Development Decisions.Journal of clinical pharmacology · 2026Review
- QSP-Copilot: An AI-Augmented Platform for Accelerating Quantitative Systems Pharmacology Model Development.CPT: pharmacometrics & systems pharmacology · 2025Article
- An industry perspective on current QSP trends in drug development.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Towards a comprehensive assessment of QSP models: what would it take?Journal of pharmacokinetics and pharmacodynamics · 2024Review
- Machine learning progressive CKD risk prediction model is associated with CKD-mineral bone disorder.Bone reports · 2024Article
- Information geometry for multiparameter models: new perspectives on the origin of simplicity.Reports on progress in physics. Physical Society (Great Britain) · 2022Review
- Artificial intelligence-guided precision treatment of chronic kidney disease-mineral bone disorder.CPT: pharmacometrics & systems pharmacology · 2022Article
- Deciphering albumin-directed drug delivery by imaging.Advanced drug delivery reviews · 2022Review
- A model-based analysis to guide gonadotropin-releasing hormone receptor antagonist use for management of endometriosis.British journal of clinical pharmacology · 2022Article
- From data to QSP models: a pipeline for using Boolean networks for hypothesis inference and dynamic model building.Journal of pharmacokinetics and pharmacodynamics · 2022Article
- Article
- An Early Stage Researcher's Primer on Systems Medicine Terminology.Network and systems medicine · 2021Review
- In silico trials predict that combination strategies for enhancing vesicular stomatitis oncolytic virus are determined by tumor aggressivity.Journal for immunotherapy of cancer · 2021Article
- Development of a quantitative systems pharmacology model of chronic kidney disease: metabolic bone disorder.American journal of physiology. Renal physiology · 2021Article
- A Mechanistic Site-Of-Action Model: A Tool for Informing Right Target, Right Compound, And Right Dose for Therapeutic Antagonistic Antibody Programs.Frontiers in bioinformatics · 2021Article
- Cardiorenal Systems Modeling: Left Ventricular Hypertrophy and Differential Effects of Antihypertensive Therapies on Hypertrophy Regression.Frontiers in physiology · 2021Article
- A Dynamic Quantitative Systems Pharmacology Model of Inflammatory Bowel Disease: Part 2 - Application to Current Therapies in Crohn's Disease.Clinical and translational science · 2021Article
- Improving nanotherapy delivery and action through image-guided systems pharmacology.Theranostics · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.