Alendronate intra-subject CV [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2006-10-30 15:59 (7178 d 04:21 ago) – Posting: # 343
Views: 8,755

Dear Joy,

with a little algebra you can calculate CVintra from confidence intervals (CIs) and the sample size given in any published study. :-D

Roldán EJ, Quattrocchi O, Zanetti D, Piccinni E, Tessler J, Caballero LE, Lloret AP
In vitro and in vivo equivalence studies of alendronate monosodium tablets
Arzneimittelforschung / Drug Res. 2005; 55/2: 93-101

Urine, 23 subjects:
Ae0-36h: CI 72%-122% (CVintra 55.7%)

Almeida S, Almeida A, Filipe A, Penedo C, Rocha A, Lainesse A, Vallée F
In vitro disintegration and dissolution and in vivo bioequivalence of two alendronate once-weekly formulations
Arzneimittelforschung / Drug Res. 2006; 56/2: 84-89

Urine, 70 subjects
Ae0-36h: CI 98.67%-118.99% (CVintra 34.2%)
Rmax: CI 102.22%-122.46% (CVintra 32.9%)
CV 32-35% (stated in reference)

Yun MH, Woo JS, Kwon KI
Bioequivalence and pharmacokinetics of 70 mg alendronate sodium tablets by measuring alendronate in plasma
Arch Pharm Res. 2006 Apr; 29/4: 328-332
online resource (1.99MB PDF)

Plasma, 24 subjects:
AUC0-7h: CI 82.34%-115.97% (CVintra 35.6%)
Cmax: CI 82.22%-114.09% (CVintra 34.0%)

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