Table III.
Simulated and Experimental Results Obtained on Bioequivalence Studies of Efavirenz Biobatches A and B
| Pharmacokinetic parametera | Bioequivalence study A | Bioequivalence study B | ||||||
|---|---|---|---|---|---|---|---|---|
| Reference drug A | Biobatch A | Reference drug B | Biobatch B | |||||
| Simulated | Experimental results | Simulated | Experimental results | Simulated | Experimental results | Simulated | Experimental results | |
| C max (μg/mL) | 3.14 ± 0.23 | 3.74 ± 0.68 | 2.78 ± 0.43 | 2.93 ± 0.83 | 2.34 ± 0.87 | 2.92 ± 0.88 | 0.77 ± 0.62 | 1.09 ± 0.44 |
| T max (h) | 3.0 ± 1.2 | 2.7 ± 1.0 | 3.4 ± 0.76 | 4.5 ± 1.8 | 4.5 ± 0.98 | 3.0 ± 5.0 | 3.6 ± 0.91 | 4.5 ± 23.63 |
| AUC 0 – t (μg h/mL) | 139.42 ± 13.0 | 121.03 ± 42.64 | 131.27 ± 16.24 | 137.95 ± 42.85 | 99.80 ± 17.4 | 100.03 ± 24.55 | 50.64 ± 29.33 | 65.10 ± 16.45 |
| AUC 0 – ∞ (μg h/mL) | 163.28 ± 22.71 | 163.38 ± 74.37 | 187.6 ± 19.11 | 184.52 ± 52.63 | 135.39 ± 15.9 | 138.27 ± 49.23 | 69.75 ± 15.53 | 92.86 ± 34.68 |