ArticleThe AAPS journal2021
FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective.
Article in The AAPS journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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Who cites it
25 citing papers in PubMed.
- Quantitative Systems Pharmacology (QSP): Bridging Biology and Mechanism with Clinical Drug Development Decisions.Journal of clinical pharmacology · 2026Review
- NX210c Demonstrates Therapeutic Potential to Restore Blood-Brain Barrier in a QSP Model of Relapsing-Remitting Multiple Sclerosis.International journal of molecular sciences · 2026Article
- A Step-by-Step Workflow for Performing In Silico Clinical Trials With Nonlinear Mixed Effects Models.CPT: pharmacometrics & systems pharmacology · 2025Article
- How does mathematical modeling improve our understanding and design of biological immunomodulators?Therapeutic delivery · 2025Article
- The dawn of a new era: can machine learning and large language models reshape QSP modeling?Journal of pharmacokinetics and pharmacodynamics · 2025Review
- Modernizing Preclinical Drug Development: The Role of New Approach Methodologies.ACS pharmacology & translational science · 2025Review
- Unlocking the Mysteries of Rare Disease Drug Development: A Beginner's Guide for Clinical Pharmacologists.Clinical and translational science · 2025Review
- A Multiple-Model-Informed Drug-Development Approach for Optimal Regimen Selection of an Oncolytic Virus in Combination With Pembrolizumab.CPT: pharmacometrics & systems pharmacology · 2025Article
- A Framework for Quantitative Systems Pharmacology Model Execution.Handbook of experimental pharmacology · 2025Review
- What Is QSP and Why Does It Exist?: A Brief History.Handbook of experimental pharmacology · 2025Review
- Towards a comprehensive assessment of QSP models: what would it take?Journal of pharmacokinetics and pharmacodynamics · 2024Review
- Current practices for QSP model assessment: an IQ consortium survey.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Assessing the performance of QSP models: biology as the driver for validation.Journal of pharmacokinetics and pharmacodynamics · 2024Review
- An industry perspective on current QSP trends in drug development.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Leveraging multi-omics data to empower quantitative systems pharmacology in immuno-oncology.Briefings in bioinformatics · 2024Article
- An integrative mechanistic model of thymocyte dynamics.Frontiers in immunology · 2024Article
- Advancing precision medicine therapeutics for Parkinson's utilizing a shared quantitative systems pharmacology model and framework.Frontiers in systems biology · 2024Article
- In Silico Pharmacology for Evidence-Based and Precision Medicine.Pharmaceutics · 2023Article
- Variability and uncertainty: interpretation and usage of pharmacometric simulations and intervals.Journal of pharmacokinetics and pharmacodynamics · 2022Article
- Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The pharmaceutical industry is actively applying quantitative systems pharmacology (QSP) to make internal decisions and guide drug development. To facilitate the eventual development of a common framework for assessing the credibility of QSP models for clinical drug development, scientists from US Food and Drug Administration and the pharmaceutical industry organized a full-day virtual Scientific Exchange on July 1, 2020. An assessment form was used to ensure consistency in the evaluation process. Among the cases presented, QSP was applied to various therapeutic areas. Applications mostly focused on phase 2 dose selection. Model transparency, including details on expert knowledge and data used for model development, was identified as a major factor for robust model assessment. The case studies demonstrated some commonalities in the workflow of QSP model development, calibration, and validation but differ in the size, scope, and complexity of QSP models, in the acceptance criteria for model calibration and validation, and in the algorithms/approaches used for creating virtual patient populations. Though efforts are being made to build the credibility of QSP models and the confidence is increasing in applying QSP for internal decisions at the clinical stages of drug development, there are still many challenges facing QSP application to late stage drug development. The QSP community needs a strategic plan that includes the ability and flexibility to Adapt, to establish Common expectations for model Credibility needed to inform drug Labeling and patient care, and to AIM to achieve the goal (ACCLAIM).
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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.