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Table 4 Statistical results of fasting oseltamivir pharmacokinetic parameters—sensitivity analysis

From: Oseltamivir phosphate for suspension is bioequivalent to TAMIFLU in healthy volunteers: a randomized, open-label clinical study

PK parameters (unit)

GLSM and ratio

CV (%)

90%CI

Power (%)

Test product

Reference product

T/R(%)

(N)

(N)

Cmax

(ng/mL)

45.9571 (39)

45.7018 (40)

100.56

18.58

(93.73,107.88)

 > 99.9

AUC0-t

(h*ng/mL)

144.6536 (39)

146.6111 (40)

98.66

10.09

(94.95,102.53)

 > 99.9

AUC0-∞

(h*ng/mL)

148.9203 (39)

150.6285 (40)

98.87

10.45

(95.01,102.88)

 > 99.9

  1. CV (%) Intraindividual variation, Coefficient of variation, Cmax Maximum plasma concentration, AUC0-t Area under the plasma concentration–time curve from time 0 to last time Concentration, AUC0-∞ Area under the plasma concentration–time curve from time zero extrapolated to infinite time, GLSM Geometric least squares mean
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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