ArticleJournal of pharmacokinetics and pharmacodynamics2024
An industry perspective on current QSP trends in drug development.
Article in Journal of pharmacokinetics and pharmacodynamics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Quantitative Systems Pharmacology Models of Anti-Amyloid Treatments for Alzheimer's Disease: A Systematic Review.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- Trial
- Quantitative Systems Pharmacology (QSP): Bridging Biology and Mechanism with Clinical Drug Development Decisions.Journal of clinical pharmacology · 2026Review
- Bayesian Workflow for Minimal PBPK Models: Case Study of Dapagliflozin.CPT: pharmacometrics & systems pharmacology · 2026Article
- Application of Model-Informed Approaches in Neuroscience Drug Development and Regulatory Decision-Making.Journal of clinical pharmacology · 2026Review
- Model-Informed Drug Development: Addressing the Critical Need for Training in the Promising New Field.Delaware journal of public health · 2026Article
- Tackling High Dimensionality in QSP: Guiding Model Order Reduction With Index Analysis.CPT: pharmacometrics & systems pharmacology · 2026Article
- NX210c Demonstrates Therapeutic Potential to Restore Blood-Brain Barrier in a QSP Model of Relapsing-Remitting Multiple Sclerosis.International journal of molecular sciences · 2026Article
- Quantitative systems pharmacology model of B cell immune response in mouse.Frontiers in immunology · 2026Article
- Model-Informed Drug Development (MIDD) for Analgesics: Review of Applications, Regulatory Integration, and Emerging Directions.Journal of pain research · 2026Review
- Quantitative Approaches to Accelerate MASH Drug Discovery and Development.Clinical pharmacology and therapeutics · 2025Review
- Practical Pharmacokinetic-Pharmacodynamic Models in Oncology.Pharmaceutics · 2025Review
- QSP-Copilot: An AI-Augmented Platform for Accelerating Quantitative Systems Pharmacology Model Development.CPT: pharmacometrics & systems pharmacology · 2025Article
- Mechanistic data-informed multiscale quantitative systems pharmacology modeling framework enables the clinical translation and efficacy assessment of CAR-T therapy in solid tumors.Journal for immunotherapy of cancer · 2025Article
- Integrating Pharmacokinetics and Quantitative Systems Pharmacology Approaches in Generative Drug Design.Journal of chemical information and modeling · 2025Article
- The Evolution of Systems Biology and Systems Medicine: From Mechanistic Models to Uncertainty Quantification.Annual review of biomedical engineering · 2025Review
- Unraveling the synergy of radiotherapy and immune checkpoint inhibitors in NSCLC: emerging clinical evidence and novel therapeutic strategies.Frontiers in oncology · 2025Review
- Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk.Frontiers in immunology · 2025Article
- Conceptual quantitative systems pharmacology framework for supporting clinical trial design in organ-specific autoimmune and rare diseases.Frontiers in immunology · 2025Review
- Editor's note on the themed issue: assessing QSP models and amplifying their impact.Journal of pharmacokinetics and pharmacodynamics · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
2023 marks the 10th anniversary of Natpara's submission to the US FDA, which led to the first recorded regulatory interaction where a decision was supported by Quantitative and Systems Pharmacology (QSP) simulations. It had taken about 5 years for the timid QSP discipline to emerge as an effective Model-Informed Drug Development (MIDD) tool with visible impact in the pharmaceutical industry. Since then, the presence of QSP in the regulatory environment has continued to increase, to the point that the Agency reported 60 QSP submissions in 2020 alone, representing ~ 4% of their annual IND submissions [1]. What sort of industry mindset has enabled QSP to reach this level of success? How does QSP fit within the MIDD paradigm? Does QSP mean the same to Discovery and to Clinical Development projects? How do 'platforms' compare to 'fit-for-purpose' QSP models in an industrial setting? Can QSP and empirical Pharmacokinetic-Pharmacodynamic (PKPD) modelling be complementary? What level of validation is required to inform drug development decisions? This article reflects on all these questions, in particular addressing those audiences with limited line-of-sight into the drug industry decision-making machinery.
Indexed as
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.