TABLE 3

Predicted human and observed human hepatic clearance for compounds without the potential for biliary excretion as the major clearance pathway

CompoundObserved CLHPredicted CLH Method 1Predicted CLH Method 2Observed CLH,intPredicted CLH,int Method 1Predicted CLH,intMethod 2Reference for Observed Values
ml/min per kilogramml/min per kilogramml/min per kilogramml/min per kilogramml/min per kilogramml/min per kilogram
Diclofenac4.16.50.6715003400190Willis et al., 1979; NDA-207238, 2017
Ibuprofen0.890.930.71798362Bushra and Aslam, 2010; Pavliv et al., 2011
Meloxicam0.160.0930.04520115.5Schmid et al., 1995
Nateglinide1.31.50.3512015030Weaver et al., 2001
Tolbutamide0.180.460.156.1165.0Scott and Poffenbarger, 1979; Flesch et al., 1997
Atorvastatin8.95.41.789022041Lennernas, 2003
Bosentan2.22.00.52928419Weber et al., 1996
Cerivastatin2.72.60.8920019055Muck et al., 1997; Muck, 2000
Fluvastatin7.34.20.911700660110Tse et al., 1992; Lindahl et al., 1996
Glipizide0.530.550.2114145.3Pentikainen et al., 1983
Glyburide1.20.600.1858026078Neugebauer et al., 1985; Varma et al., 2009
GSK269984A2.03.80.639802200280Ostenfeld et al., 2012
Irbesartan2.12.40.6416020043Vachharajani et al., 1998
Montelukast0.570.991.8640012,00023,000Cheng et al., 1996; Balani et al., 1997
Pitavastatin5.60.530.2814007036NDA-022363, 2009
Repaglinide7.32.61.51000250140Hatorp et al., 1998; NDA-020741, 2017
Telmisartan101.80.2710,00036047Stangier et al., 2000a,b
Theophylline0.874.01.81.38.02.9Conrad and Nyman, 1980; Caldwell et al., 1986; Vestal et al., 1986; Lombardi et al., 1987; NDA-019211, 2009
Timolol6.44.84.0149.37.3Wilson et al., 1982; McGourty et al., 1985
N19191919
AFE1.94.12.55.8
bias0.840.300.710.21
  • ECCS, extended clearance classification system.