Topic: Case Studies: Questions, Evidence and Decisions

Using a Pharmacodynamic Biomarker for Phase I Dose Escalation

Using Accumulation Data to Set a Phase I Dosing Interval

Using Exposure-QTc Evidence to Select a Cardiac Safety Margin

Using Maturation Models to Select Infant Doses

Using Therapeutic Drug Monitoring to Individualize Dosing

Valuing a New Study With Expected Value of Information

Updating a Labeled Dose After New Post-Marketing PK Data

Using a Failed Phase II Trial to Revise the Development Plan

Tracing a Go-or-No-Go Decision From Question to Residual Risk

Translating a DDI Model Into Labeling Instructions