Table 5. Pharmacodynamic parameters of three generics and the innovator of FLC against C. albicans CIB-19177 (MIC = 4.0 mg/L) in the neutropenic mouse model of disseminated candidiasis.
| PD Parameter(Units) | Mean PD Parameter Value of Fluconazole products (±SE) | ||||
|---|---|---|---|---|---|
| Pfizer (innovator) | Claris | Fresenius | Vitalis | Global Curve* | |
| E 0 (log 10 CFU/g) | 5.93 (0.13) | 6.02 (0.19) | 6.12 (0.20) | 6.00 (0.22) | 5.99 (0.09) |
| E max (log 10 CFU/g) | 2.83 (0.18) | 2.55 (0.28) | 3.09 (0.28) | 3.40 (0.39) | 2.91 (0.13) |
| ED 50 (mg/kg) | 22.6 (1.17) | 18.9 (2.17) | 22.5 (1.74) | 26.2 (3.00) | 22.5 (0.92) |
| fAUC/MIC for ED 50 | 25.2 (1.31) | 21.1 (2.43) | 25.1 (1.95) | 29.3 (3.35) | 25.1 (1.03) |
| N (Hill’s slope) | 5.00 (1.13) | 2.98 (0.95) | 4.70 (1.48) | 2.72 (0.80) | 3.83 (0.55) |
| Adj.R 2 | 0.89 | 0.87 | 0.89 | 0.89 | 0.88 |
| S y|x (log 10 CFU/g) | 0.42 | 0.37 | 0.46 | 0.46 | 0.44 |
*The P-value from the CFA was 0.08, indicating that a single global curve described all data. E max, maximum effect; ED 50, effective dose achieving 50% of the E max; N, slope; Adj.R2, adjusted coefficient of determination; Sy|x, standard error of estimate; SE, standard error of the mean; CFA, curve-fitting analysis.