Topic: First-in-Human Dose Selection

Choosing Cmax or AUC as the Dose-Limiting Exposure

Choosing Relevant Species for First-in-Human Dose Calculations

Choosing the Controlling Margin When Endpoints Disagree

Calculating Safety Factors After HED Conversion

Allometric Scaling of Clearance Across Species

Auditing Units and Conversion Steps in Dose Calculations

Accounting for Route and Bioavailability in Starting-Dose Calculations