Table 4

Area under the effect curve (AUEC), AUEC ratio (HX575/comparator), 90% confidence intervals and ANOVA coefficient of variation over days 1–29 of the study for the AUECs of the haematological parameters.

Haematological parameter

HX575

Comparator

Ratio (%)

90% CI (%)

ANOVA-CV (%)

AUEC_Hb (g/dL*h) – GeoM

10049.4

10064.3

99.9

98.5–101.2

3.6

AUEC_Hb (g/dL*h) – GeoCV

3.5%

3.6%

-

-

AUEC_RBC (10⁶/μL*h) – GeoM

3318

3298

100.6

98.5–102.7

5.4

AUEC_RBC (10⁶/μL*h) – GeoCV

5.5%

5.4%

-

-

AUEC_HCT (%*h) – GeoM

28796

28912

99.6

98.2–101.0

3.7

AUEC_HCT (%*h) – GeoCV

4.1%

3.3%

-

--

AUEC_RET (h*10⁹/L) – GeoM

85577

87070

98.3

93.0–103.9

14.5

AUEC_RET (h*10⁹/L) – GeoCV

13.3%

15.6%

-

-

GeoM = geometric mean; GeoCV = coefficient of variation of GeoM; CI = confidence interval; ANOVA-CV = ANOVA coefficient of variation. Method used to calculate the 90% CI: ANOVA on log-transformed data. The treatments were considered bioequivalent if the ratio and 90% CI of the AUEC_hb fell within the range of 96.8–103.2%. The other parameters were considered bioequivalent if the respective AUEC ratio and 90% CI fell within the range of 80–125%. Number of subjects analysed: n = 37 (HX575) and n = 39 (comparator).

Sörgel et al. BMC Clinical Pharmacology 2009 9:10   doi:10.1186/1472-6904-9-10