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 Sound Pharmaceuticals.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Otolaryngology · Cochlear Implant
- Sub-indication
- General
Related signal: SPI-1005 Trial for Adults with Cochlear Implants Shows Potential for Side Effect Management