The US Food and Drug Administration's Model‐Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact
Abstract
The authors declared no competing interests for this work.
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A potential mechanism for discussions with regulators on the COU, model risk, and V&V plan is the MIDD pilot program, where early engagement aims to help accelerate drug development through discussion of modeling and simulation strategies, with the potential to reduce late-stage drug development failures.
“A potential mechanism for these discussions is the MIDD pilot program, where early engagement aims to help accelerate drug development through discussion of modeling and simulation strategies, with the potential to reduce late‐stage drug development failures.19”
Cites
Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations
Wang, Y., Zhu, H., Madabushi, R., Liu, Q., Huang, S., & Zineh, I. (2019) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1363 · Cited by 228 · see citing works
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Kuemmel, C., Yang, Y., Zhang, X., Florian, J., Zhu, H., Tegenge, M., Huang, S., Wang, Y., Morrison, T., & Zineh, I. (2020) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12479 · Cited by 177 · see citing works
Self-citation
- Authors
- Madabushi, R., Benjamin, J. M., Grewal, R., Pacanowski, M. A., Strauss, D. G., Wang, Y., Zhu, H., & Zineh, I.
- Affiliations
- United States Food and Drug Administration (US)
- Corresponding author
- Zineh, Issam
- Venue
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2019-05-13
- Volume
- 106
- Issue
- 1
- Pages
- 74-78
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- OpenAlex
- W2946299830
- Cited by
- 39
- References
- 1
- Citations by year
- 2026: 5 · 2025: 3 · 2024: 8 · 2023: 4 · 2022: 4 · 2021: 9 · 2020: 4 · 2019: 2
- FWCI
- 4.94
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Food and Drug Administration
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- model-informed drug development, pilot project, regulatory science, drug development, regulatory decision-making, clinical pharmacology
- MeSH terms
- Drug Development, Humans, Product Surveillance, Postmarketing, United States, United States Food and Drug Administration, Drug Approval, Interdisciplinary Communication
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