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: sets a safety guidance precedent in the same sub-indication (immunology) as AbbVie.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Dermatology · Atopic Dermatitis
- Sub-indication
- Immunology
Related signal: AbbVie Trials Upadacitinib for Moderate-to-Severe Atopic Dermatitis in Dupilumab Inadequate Responders