Regulatory science, Drug development tools (DDTs)

This web app has an overview on Regulatory science and Drug development tools (DDTs), in different stages of their development and based on information made publicly available by the EMA and FDA. Developers of such tools include academia, public-private consortia and commercial entities. Public information on qualified tools and methodologies serves the broader community of developers and researchers to use the tools for their activities and may lead to investigate expanding their context of use.

Silva, Marcio, Jane Moseley, Thorsten Vetter, Jan Regnstrom, Maria Tome, Stiina Aarum, Francesca Cerreta, Elmer Schabel, and Spiros Vamvakas. 2023. “Patient-Reported, Observer-Reported and Performance Outcomes in Qualification Procedures at the European Medicines Agency (EMA) 2013-2018.” British Journal of Clinical Pharmacology 90 (1): 299–312.
Laverty, Hugh, and Pierre Meulien. 2019. “The Innovative Medicines Initiative −10 Years of Public-Private Collaboration.” Frontiers in Medicine 6.
Hendrikse, Natalie M., Jordi Llinares Garcia, Thorsten Vetter, Anthony J. Humphreys, and Falk Ehmann. 2022. “Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond.” Frontiers in Medicine 9.

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