What is dose optimization?
Dose optimization involves systematically evaluating different dosing regimens to determine the optimal balance between therapeutic benefit and safety. This process may occur during early-phase trials or as part of post-marketing studies and can include adjustments based on age, weight, renal function, genetic factors, or disease severity.
Why is dose optimization important in clinical development and patient care?
Optimizing dose improves treatment outcomes, reduces side effects, and enhances adherence. It also supports regulatory approvals, payer confidence, and real-world use. Dose optimization data are increasingly important in value assessments and in demonstrating personalized or precision medicine approaches.
