Designing Optimal First in Human Radiopharmaceutical Trials for Translational Success: Regulatory Considerations
Time: 2:00 pm
day: Workshop C
Details:
First-in-human radiopharmaceutical trials are critical for assessing the safety, pharmacokinetics, dosimetry, and preliminary efficacy of new radiopharmaceuticals. The design of these trials must be meticulous to ensure patient safety while gathering essential data. Key components include patient monitoring duration, dose toxicity assessment, and primary readouts.
Join this workshop to:
- Uncover pre, during and post-treatment monitoring
- Determine your dose escalation and safety reviews
- Exploring dosimetry from absorbed dose calculation and dose response relationships
- Dealing with waste disposal, radiation safety and logistical challenges with alpha emitters
- Considerations for Project Optimus
