Topic: Case Studies: Questions, Evidence and Decisions

Combining PBPK and Population PK Evidence for a DDI Decision

Comparing Adaptive Dose-Selection Designs by Simulation

Comparing Allometric and Toxicology-Based Starting Doses

Choosing a Titration Schedule for a Narrow Therapeutic Window

Choosing Between Indications Under a Limited Development Budget

Bridging a New Formulation to an Established Dose

Choosing a Confirmatory Strategy for a Rare Disease

Choosing a Dose for Patients With Hepatic Impairment

Choosing a Dose for Patients With Renal Impairment

Choosing a Dose When the Efficacy Curve Plateaus