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 Astellas Pharma Inc..
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · AML
- Sub-indication
- General
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