Renal Impairment (RI) studies
CautionUnder construction
| 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)