ArticleCPT: pharmacometrics & systems pharmacology2019
Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives.
Article in CPT: pharmacometrics & systems pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 2 of them syntheses 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
56 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Applications of Model-Based Meta-Analysis in Drug Development.Pharmaceutical research · 2022Pooled it
- Longitudinal model-based meta-analysis for survival probabilities in patients with castration-resistant prostate cancer.European journal of clinical pharmacology · 2020Pooled it
- Machine Learning-Augmented Precision Dosing: Integrating Pharmacokinetic Modeling With Clinical Decision Support.CPT: pharmacometrics & systems pharmacology · 2026Review
- The Governance Gap: Democratizing Drug Development Through Decision Architecture.Clinical pharmacology and therapeutics · 2026Review
- PKPD-Based Translational Modeling of Calaspargase Pegol Preclinical Activity in Hepatocellular Carcinoma.European journal of drug metabolism and pharmacokinetics · 2026Article
- Artificial intelligence in drug discovery - what it is, where we stand and the path forward.Nature reviews. Drug discovery · 2026Review
- Beyond Body Weight: A Comprehensive Review of Allometric Scaling in Drug Development for Human Dose Predictions.Pharmaceutics · 2026Review
- Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.CPT: pharmacometrics & systems pharmacology · 2026Review
- Straight to Phase III: Model-Informed Approach Speeds Depemokimab Clinical Development in Interleukin-5-Driven Diseases.Clinical pharmacology and therapeutics · 2026Article
- Model-Informed Drug Development: Addressing the Critical Need for Training in the Promising New Field.Delaware journal of public health · 2026Article
- Model-Informed Drug Development for Ligelizumab in Patients With Chronic Spontaneous Urticaria.CPT: pharmacometrics & systems pharmacology · 2025Article
- A Pharmacometrics-Informed Trial Simulation Framework for Optimizing Study Designs for Disease-Modifying Treatments in Rare Neurological Disorders.CPT: pharmacometrics & systems pharmacology · 2025Article
- Pharmacometrics in the Age of Large Language Models: A Vision of the Future.Pharmaceutics · 2025Article
- Machine Learning Prediction and Validation of Plasma Concentration-Time Profiles.Molecular pharmaceutics · 2025Article
- Accelerating virtual patient generation with a Bayesian optimization and machine learning surrogate model.CPT: pharmacometrics & systems pharmacology · 2025Article
- Systems immunology: When systems biology meets immunology.Frontiers in immunology · 2025Review
- Leveraging machine learning models in evaluating ADMET properties for drug discovery and development.ADMET & DMPK · 2025Review
- Application of Quantitative Systems Pharmacology Approaches to Support Pediatric Labeling in Rare Diseases.Handbook of experimental pharmacology · 2025Review
- Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024Review
- Immune digital twins for complex human pathologies: applications, limitations, and challenges.NPJ systems biology and applications · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Good practices around model-informed drug discovery and development (MID3) aim to improve the implementation, standardization, and acceptance of these approaches within drug development and regulatory review. A survey targeted to clinical pharmacology and pharmacometric colleagues across industry, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) was conducted to understand current and future roles of MID3. The documented standards were generally affirmed as a "good match" to current industry practice and regulatory expectations, with some identified gaps that are discussed. All have seen at least a "modest" step forward in MID3 implementation associated with greater organizational awareness and share the expectation for a future wider use and impact. The priority within organizations was identified as a limitation with respect to the future of MID3. Finally, potential solutions, including a global overarching MID3 regulatory guideline, to facilitate greater acceptance by industry and regulatory decision makers are discussed.
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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.