ArticleCPT: pharmacometrics & systems pharmacology2021
Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration.
Article in CPT: pharmacometrics & systems pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
What it found
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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
25 citing papers in PubMed.
- Virtual clinical trials of anti-PD-1 and anti-CTLA-4 immunotherapy in advanced hepatocellular carcinoma using a quantitative systems pharmacology model.Journal for immunotherapy of cancer · 2022Trial
- Modeling and Simulation in Development and Regulatory Approval of Chimeric Antigen Receptor T-Cell Therapies: An Analysis of European Medicines Agency Centralized Procedures From 2018 to 2024.CPT: pharmacometrics & systems pharmacology · 2026Article
- Harnessing Open-Source Solutions: Insights From the First Open Systems Pharmacology (OSP) Community Conference.CPT: pharmacometrics & systems pharmacology · 2025Article
- Accelerating virtual patient generation with a Bayesian optimization and machine learning surrogate model.CPT: pharmacometrics & systems pharmacology · 2025Article
- Integrating QSP and ML to Facilitate Drug Development and Personalized Medicine.Handbook of experimental pharmacology · 2025Review
- The Role of Cross-Institutional and Interdisciplinary Collaboration in Defining and Executing a Quantitative Systems Pharmacology Strategy.Handbook of experimental pharmacology · 2025Review
- Future Directions for Quantitative Systems Pharmacology.Handbook of experimental pharmacology · 2025Review
- What Is QSP and Why Does It Exist?: A Brief History.Handbook of experimental pharmacology · 2025Review
- Quantitative Systems Pharmacology Modeling in Immuno-Oncology: Hypothesis Testing, Dose Optimization, and Efficacy Prediction.Handbook of experimental pharmacology · 2025Review
- Integrating Model-Informed Drug Development With AI: A Synergistic Approach to Accelerating Pharmaceutical Innovation.Clinical and translational science · 2025Review
- Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report.CPT: pharmacometrics & systems pharmacology · 2024Article
- Ten challenges and opportunities in computational immuno-oncology.Journal for immunotherapy of cancer · 2024Review
- An industry perspective on current QSP trends in drug development.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Current practices for QSP model assessment: an IQ consortium survey.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- From virtual patients to digital twins in immuno-oncology: lessons learned from mechanistic quantitative systems pharmacology modeling.NPJ digital medicine · 2024Review
- Applying quantitative and systems pharmacology to drug development and beyond: An introduction to clinical pharmacologists.Indian journal of pharmacology · 2024Review
- Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development.CPT: pharmacometrics & systems pharmacology · 2024Review
- Coupling quantitative systems pharmacology modelling to machine learning and artificial intelligence for drug development: itsFrontiers in systems biology · 2024Article
- Generating immunogenomic data-guided virtual patients using a QSP model to predict response of advanced NSCLC to PD-L1 inhibition.NPJ precision oncology · 2023Article
- Generating immunogenomic data-guided virtual patients using a QSP model to predict response of advanced NSCLC to PD-L1 inhibition.bioRxiv : the preprint server for biology · 2023Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Quantitative systems pharmacology (QSP) has been proposed as a scientific domain that can enable efficient and informative drug development. During the past several years, there has been a notable increase in the number of regulatory submissions that contain QSP, including Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applications (BLAs) to the US Food and Drug Administration. However, there has been no comprehensive characterization of the nature of these regulatory submissions regarding model details and intended applications. To address this gap, a landscape analysis of all the QSP submissions as of December 2020 was conducted. This report summarizes the (1) yearly trend of submissions, (2) proportion of submissions between INDs and NDAs/BLAs, (3) percentage distribution along the stages of drug development, (4) percentage distribution across various therapeutic areas, and (5) nature of QSP applications. In brief, QSP is increasingly applied to model and simulate both drug effectiveness and safety throughout the drug development process across disease areas.
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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.