The Hidden Metric – Why Dosimetry is a Pillar of Radiopharmaceutical Manufacturing & How Integrating it Early Ensures Patient Safety, Product Consistency & Regulatory Confidence
Time: 9:30 am
day: Conference Day Two
Details:
- Discover how dosimetry informs production yields and formulation volumes and how this data helps optimize radioactive content per batch and adjust for decay rates during production.
- Explore how dosimetry requirements influence formulation volume, carrier molecule concentration, and specific activity which drives critical manufacturing decisions from early development through scale-up.
- Examine the ongoing lack of standardization in dosimetry methodologies, including the use of imaging, biodistribution studies, and animal models, and how this variability affects reproducibility across programs.
- Discuss challenges in defining and applying relative biological effectiveness (RBE) for alpha particles, and its implications for accurate dose estimation, toxicity prediction, and regulatory confidence.
