TABLE 2

Effects of varying ka on estimates of Tmax and Cmax from simulated blood data, which contained 5% assay error

Values assigned were: α, β, and k21 = 0.8, 0.2, and 0.5 h−1, respectively.

ka (h−1)True ValueTwo-Compartment ModelObserved Values (FDA method)
Tmax,true (h)Tmax,2comp (h)%BiasaRSDbTmax,obs (h)%BiasRSD
30.7430.7440.181%5.67%0.7825.28%20.4%
20.9720.971−0.0257%4.62%0.947−2.58%19.9%
11.511.520.310%3.85%1.627.36%19.1%
0.15.775.75−0.351%5.08%6.014.01%21.1%
0.058.077.97−1.17%5.78%7.93−1.69%23.0%
ka (h−1)Cmax,true (μg/ml)Cmax,2comp (μg/ml)%BiasRSDCmax,obs (μg/ml)%BiasRSD
370.770.90.222%2.54%72.12.04%3.76%
264.264.1−0.0779%2.49%65.31.74%3.98%
151.951.8−0.0675%2.19%52.81.76%3.90%
0.116.316.30.338%2.62%16.62.00%3.76%
0.0510.010.10.169%2.69%10.22.09%3.81%
  • a %Bias was determined using eq. 12.

  • b RSD was determined using eq. 13.