Topic: First-in-Human Dose Selection

Estimating MABEL from Receptor Occupancy

Documenting the Rationale and Residual Risk for a Starting Dose

Diagnosing When Allometric Scaling Is Unreliable

Deriving Human Equivalent Dose from an Animal NOAEL

Deriving MABEL from In Vitro Potency and Cellular Assays

Detecting Overconservative and Underprotective Safety Margins

Defining MABEL from Mechanistic Evidence

Decomposing Safety Factors by Risk Dimension

Correcting Allometry for Physiological Differences

Comparing NOAEL-, HNSTD-, and MABEL-Based Doses