FDAsafety guidance54% 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 (pain) as Aurobindo Pharma.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Neurology · Pain Management
- Sub-indication
- Pain
Related signal: Aurobindo Pharma submits supplemental ANDA for Pregabalin