FDAsafety guidance72% 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: illustrates how regulators handled a comparable safety guidance decision relevant to Novartis.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Rheumatology · Small Molecule
- Sub-indication
- General
Related signal: Novartis initiates ascending dose study of PIT565 for rheumatoid arthritis