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)