TABLE 1

The effect of protein addition on hepatocyte clearance predictability within twofold of observed CLH, b (or CLH, p) for all drugs and separated for low (≤0.3), intermediate (>0.3–<0.7), and high (≥0.7) extraction ratio drugs

Predicted/Observed CLH, bPredicted/Observed CLH,p
Without SerumWith SerumWithout SerumWith Serum
Over TwofoldWithin TwofoldOver TwofoldWithin TwofoldOver TwofoldWithin TwofoldOver TwofoldWithin Twofold
All drugs67.6%(n = 48 of 71)32.4%(n = 23 of 71)58.9%(n = 43 of 73)41.1%(n = 30 of 73)82.1%(n = 55 of 67)17.9%(n = 12 of 67)72.5%(n = 50 of 69)27.5%(n = 19 of 69)
Low ER68.7%(n = 22 of 32)31.3%(n = 10 of 32)53.1%(n = 17 of 32)46.9%(n = 15 of 32)77.3%(n = 17 of 22)22.7%(n = 5 of 22)50.0%(n = 11 of 22)50.0%(n = 11 of 22)
Moderate ER65.5%(n = 19 of 29)34.5%(n = 10 of 29)67.7%(n = 21 of 31)32.3%(n = 10 of 31)73.3%(n = 11 of 15)26.7%(n = 4 of 15)68.7%(n = 11 of 16)31.3%(n = 5 of 16)
High ER70.0%(n = 7 of 10)30.0%(n = 3 of 10)50.0%(n = 5 of 10)50.0%(n = 5 of 10)90.0%(n = 27 of 30)10.0%(n = 3 of 30)90.3%(n = 28 of 31)9.68%(n = 3 of 31)