FDAsafety guidance83% confidence
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Astellas Pharma.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · NSCLC
- Sub-indication
- Lung Cancer
Related signal: Gilteritinib Study Launch for ALK-positive NSCLC Patients by Astellas Pharma