TABLE 4

Predicted in vivo clearance of PNU-96391 in humans by in vivo and in vitro data of rats, dogs, and monkeys


Species

Predicted CLblood in Humansa

Ratiob
l/h/kg
Rat 0.39 ± 0.16 0.92
Dog 0.65 ± 0.26 1.5
Monkey 0.49 ± 0.20 1.2
Human
0.43 ± 0.16c
-
  • -, not applicable.

  • a Predicted value was calculated from the normalization method: (in vitro hepatic clearance in humans) × (in vivo clearance in animal species)/(in vitro hepatic clearance in animal species). Values are expressed as mean ± S.D. (n = 8)

  • b Ratio of predicted CLblood to the observed value in humans (0.43 ± 0.16 l/h/kg)

  • c The observed value obtained from the clinical studies (n = 39)