Table 1.
Fluconazole products included in the study.
Table 2.
Geometric mean MICs (range) of fluconazole products against 6 Candida strains.
Table 3.
Population pharmacokinetics in mice of three generic products and the innovator of fluconazole.
Fig 1.
Pharmacodynamics of FLC generic products compared with the innovator against C. albicans GRP-0144.
Data from three independent experiments were combined and analyzed by CFA. The innovator (Diflucan) and Claris products were included in all three experiments (54 animals per product), Fresenius in two (36 animals) and Vitalis in one (18 animals). A single curve (solid black line) described the data better than individual ones, indicating that the generics were therapeutically equivalent to the innovator. The horizontal dotted line indicates the fungal load at the beginning of therapy (0 h).
Table 4.
Pharmacodynamic parameters of three generics and the innovator of FLC against C. albicans GRP-0144 (MIC = 0.25 mg/L) in the neutropenic mouse model of disseminated candidiasis.
Fig 2.
Pharmacodynamics of FLC generic products compared with the innovator against C. albicans CIB-19177.
Data from two independent experiments were combined and analyzed by CFA. The innovator (Diflucan) was included in both experiments (42 animals), and Claris, Fresenius and Vitalis in one (21 animals per product). A single curve (solid black line) described the data better than individual ones, indicating that the generics were therapeutically equivalent to the innovator. The horizontal dotted line indicates the fungal load at the beginning of therapy (0 h).
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.