RE: Clinical data very important30 Apr 2025 08:28
Physiomics plc
1,852 followers
15h
The FDA’s finalised guidance on dose optimisation marks a major shift in how oncology drugs are developed. In Part 1 of our latest article with Weatherden, we looked at how the guidance is shaping expectations around earlier dose exploration, stronger PK/PD data collection, and trial designs that support better risk–benefit decisions for patients. By improving dose justification and aiming to reduce unnecessary toxicity to patients, the changes have important implications across drug development, regulatory review and investment. Part 2 is coming soon, where we'll be taking a closer look at the role of Model-Informed Drug Development (MIDD) in supporting smarter dose selection.