FDA CDER just established a new center of excellence for "Quantitative Medicine". From the announcement on a public meeting on the center, Quantitative Medicine "QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care. " That would seem to put bioanalytical and biomarker measurements center stage. Info on the virtual workshop are at this link.
<https://www.fda.gov/drugs/news-events-human-drugs/streamlining-drug-development-and-improving-public-health-through-quantitative-medicine-introduction?utm_medium=email&utm_source=govdelivery#event-information>
#FDA #CDER #quantitativemedicine
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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