Strategic Dose Escalation Models to Accelerate Proof-of-Concept & Ensure Safety in First-in-Human Radioconjugate Studies
- Designing hybrid escalation schemes that balance rapid concept validation with cohort size requirements
- Incorporating interim analyses and adaptive dose-finding to minimise patient numbers and time to biologically active exposure 2.10 Optimising Control Strategies & Release Testing to Maximise Radiopharmaceutical Shelf Life & Clinical Readiness
- Tailoring analytical and release strategies from early clinical to commercial stages to ensure product integrity
- Innovations in rapid-release methods and predictive analytics to reduce time-to-patient
- Aligning starting mass and radioactivity doses with preclinical dosimetry to optimise safety margins