How AI Transforms Regulatory Submission: Current Clinical Implementation and Future Prospects
Year: 2025
Type: article
Abstract: Artificial Intelligence (AI) is transforming drug development and regulatory submission by enabling advanced data analytics, predictive modeling and intelligent decision support systems. Beyond efficiency gains, AI establishes a translational bridge between model-informed drug development (MIDD) and clinical implementation, turning regulatory evidence into actionable insights that enhance therapeutic precision and patient outcomes. This perspective paper explores AI's current applications, regulatory integrations, and future prospects in accelerating data-driven, patient-centered drug development.
DOI: 10.1111/cts.70434
Authors: Jagdeep T. Podichetty, Anna‐Marika Bauer, Rachel Xu, Nick Henscheid, Wes Anderson, Ayan Khan, Shu Chin Ma, Huong Huynh, Klaus Romero
Institution: Critical Path Institute
Language: English
Subfield: Health Informatics
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,630
OpenAlex ID: W4416980053