Optimizing Radiopharmaceutical Dosing Within FDA Guidance: Strategies to Maximize Efficacy & Minimize Toxicity
- Interpreting current FDA guidance on dose selection, escalation, and optimization for radioligand therapies
- Integrating pharmacokinetics, biodistribution, and safety data to refine patient-specific dosing strategies
- Applying regulatory best practices to design trials that balance therapeutic efficacy with minimization of off-target toxicity