Topic: First-in-Human Dose Selection

Worked Example: Receptor-Occupancy MABEL

Worked Example: Allometric NOAEL-Based Starting Dose

Worked Example: Integrating MABEL and Toxicology

Using Animal Pharmacokinetics to Convert NOAEL to Human Exposure

Translating Human Pharmacology into an Exposure Target

Starting Doses for Biologics with No Relevant Species

Setting Exposure-Based Safety Margins for Cmax and AUC

Selecting a Starting Dose Under Conflicting Evidence

Selecting Species-Specific Body-Surface-Area Factors

Sensitivity Checks for Starting-Dose Assumptions