Assessing the Impact of Confounded Time-Averaged Exposure in Logistic Regression Exposure-Response Analyses

Objectives: Exposure-response (ER) analyses are an integral part of model-informed drug development, playing a key role in evaluating the risk-to-benefit ratio for dose selection, justification, and confirmation. In the context of logistic regression analyses with binary endpoints (such as objective response rate for efficacy or treatment-emergent adverse events [TEAEs] for safety), the selection and derivation […]