Article Figures & Data
Tables
- TABLE 1.
Matrix of Differences Between Drug and Radiopharmaceutical Development Trial Phases and Proposed Alternative Nomenclature
Agent class Nomenclature Primary aim Secondary aim Eligibility Drug Phase I Safety (MTD) Efficacy Narrow Radiopharmaceutical Phase A (acquisition optimization) Temporal profile of biodistribution Radiation dosimetry (safety) Broad Drug Phase II Efficacy Expanded safety data Narrow Radiopharmaceutical Phase B (biologic relevance) Diagnostic performance Definition of target populations Broad Drug Phase III Comparison with SOC Expanded safety data Broad Radiopharmaceutical Phase C (clinical applicability) Impact on management after SOC Incremental diagnostic information Narrow MTD = maximum tolerated dose; SOC = standard of care.
In this issue
Jump to section
Related Articles
Cited By...
- No citing articles found.