Topic: Early-Phase Exposure-Response

Evaluating Exposure-Response Coverage in Escalation Cohorts

Effect Compartments and Hysteresis in Early-Phase Data

Diagnostics for Biomarker Exposure-Response Models

Direct-Effect Emax Models for Biomarker Response

Distinguishing Target Engagement, Pharmacodynamic, and Surrogate Biomarkers

Baseline and Time-Course Controls in Phase I

Baseline-Dependent Biomarker Effects

Biomarker Assay Performance and Sampling Windows