ArticleClinical pharmacology and therapeutics2025
Impact of Model-Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost.
Article in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed.
- Re-engineering insulin for oral delivery: structural modifications, advanced formulation strategies, and future directions.Drug delivery · 2026Review
- Sustainability in Pharmaceutical Research and Development: A Perspective on Opportunities for Clinical Pharmacology and Translational Sciences.Clinical pharmacology and therapeutics · 2026Article
- Bridging data and theory: hybrid modelling for pharmaceutical crystallisation process development.Digital discovery · 2026Review
- Integrating Patient-Centric Clinical Pharmacology and MID3 to Advance Biologic Development in Immune-Mediated Inflammatory Diseases.Clinical pharmacology and therapeutics · 2026Review
- Sex-Related Differences in Physiologically-Based Biopharmaceutics Modeling.CPT: pharmacometrics & systems pharmacology · 2026Article
- Application of Model-Informed Approaches in Neuroscience Drug Development and Regulatory Decision-Making.Journal of clinical pharmacology · 2026Review
- Empowering Clinical Development With Disease Progression Modeling: Recommendations From the Clinical Trials Transformation Initiative.Clinical and translational science · 2026Article
- Current State-of-the-Art and Future Advancements of Model-Based Meta-Analysis.CPT: pharmacometrics & systems pharmacology · 2026Article
- Advancing Pharmacometrics in Africa: Insights and Perspectives From the 2025 Pharmacometrics Africa Conference.Clinical pharmacology and therapeutics · 2026Article
- From Models to Medicines: A Narrative History and Regulatory Perspective on the Translational Impact of Model-Informed Drug Development (MIDD).Clinical and translational science · 2026Review
- PKRxiv: A Best Practice Model for Advancing Pharmacoequity Through Open Pharmacokinetic Data Sharing.Clinical pharmacology and therapeutics · 2026Article
- Global Trends in Integrating Machine Learning (ML) with Model-Informed Drug Development (MIDD): A Bibliometric and Systematic Review (2015-2025).Pharmaceutics · 2026Review
- Straight to Phase III: Model-Informed Approach Speeds Depemokimab Clinical Development in Interleukin-5-Driven Diseases.Clinical pharmacology and therapeutics · 2026Article
- When Survival Improves But Quality of Life Does Not: A Model-Based Meta-Analysis of Immune Checkpoint Inhibitors.medRxiv : the preprint server for health sciences · 2026Article
- Model-Informed Drug Development (MIDD) for Analgesics: Review of Applications, Regulatory Integration, and Emerging Directions.Journal of pain research · 2026Review
- Practical Pharmacokinetic-Pharmacodynamic Models in Oncology.Pharmaceutics · 2025Review
- The Three Musketeers in Cancer Therapy: Pharmacokinetics, Pharmacodynamics and Personalised Approach.Journal of personalized medicine · 2025Review
- Scoping review of the role of pharmacometrics in model-informed drug development.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- Advancing drug development with "Fit-for-Purpose" modeling informed approaches.Journal of pharmacokinetics and pharmacodynamics · 2025Review
- Advances in Drug Discovery for Cardiomyocyte Proliferation.Current treatment options in cardiovascular medicine · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Model-informed drug development (MIDD) integrates data to quantify benefit/risk informing objective drug discovery and development decisions. An additional critical benefit of MIDD is postulated to be improvement in trial and program efficiencies. While the application of MIDD has grown, there have been no clear examples across programs to demonstrate its value at the portfolio level. This manuscript offers a methodology and examples to demonstrate MIDD value in terms of time and cost savings. We utilized an algorithm to estimate savings based on MIDD-related activities at each stage of development across the entire drug development portfolio during a typical year between 2021 and 2023. This algorithm, although company-specific, demonstrated general applicability across several programs of the portfolio. Overall, the use of MIDD yielded annualized average savings of approximately 10 months of cycle time and $5 million per program. Systematic application of MIDD approaches yielded significant time and cost savings across the drug development portfolio in addition to informing data-driven decisions. Increased utilization of MIDD approaches is a driver for improving drug development efficiency.
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.