Renal Impairment (RI) studies
RI severity | GFR (mL/min) |
---|---|
Normal | > 90 |
Mild | 60–90 |
Moderate | 30–60 |
Severe (differs between FDA and EMA) | < 30, not requiring dialysis (EMA) |
ESRD (differs between FDA and EMA) | < 15, requiring dialysis |
Studies:
Full or reduced. Subjects “HV”, apart from the RI. Full: All RI groups Reduced: Only Normal, severe, and ESRD.
6-8 subjects in each RI group. This gives 80% power to detect plus/minus 40% change in exposure.
When: Almost all small molecules. Biologics <69 kDa
When not: mAbs (>69 kDa)