For molecules with novel and complex MOA (e.g., ADCs, TCEs), there is an increasing trend for these molecules to adopt multiscale mechanistic QSP models to support dosage selection. 18 , 24 These models play a pivotal role in guiding data‐driven dose decisions throughout development, from first‐in‐human starting doses to expansion doses and recommended Phase II/III doses.
← all excerpts
Oncology Dose Optimization: Tailored Approaches to Different Molecular Classes.
1
—
—