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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. This has spawned a movement focused on optimizing dose selection in oncology drug development.

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Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. What to look for in 2024: This year, OCE amassed a significant volume of feedback from its advisory committee members and from stakeholders via the rulemaking process on trial design.

FDA 40