Topic: Case Studies: Questions, Evidence and Decisions

Testing Whether a Development Decision Depends on One Assumption

Testing Whether a Population PK Covariate Merits Dose Adjustment

Simulating Trial Outcomes Under a Strong Placebo Response

Separating Exposure Effects From Time-Varying Confounding

Setting Benefit-Risk Weights for a Treatment Decision

Selecting a First Dose With a MABEL Model

Selecting a Patient-Reported Endpoint With Longitudinal Models

Selecting a Phase II Dose With a Shallow Efficacy Curve

Resolving Discordant Biomarker and Tolerability Signals

Responding to a Post-Marketing Safety Signal With Model-Based Evidence