Module232025

5/7/2025

• Draft FDA GfI - Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (JAN 2023) Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases | FDA

• CDDF Dose optimization workshop (Apr 2023) CDDF Dose optimization workshop | CDDF 5 Recent initiatives

• 2 nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right (Sept 2023) Second Annual FDA ASCO WORKSHOP on Getting the Dosage Right SEPTEMBER 6-7, 2023 - 09/06/2023 | FDA • • FDA ISoP Workshop on Quantitative Methods in Dosage Optimization of Oncology Products (Oct & Nov 2023) Workshop on Quantitative Methods in Dosage Optimization of Oncology Products (go-isop.org) • First in Human Clinical Trials with Investigational Medicinal Products (EMA 2007) and Guidance for Estimating the Maximum Safe Starting Dose (FDA 2005).

References

35

35

18