An Individual Bioequivalence Approach to Compare the Intrasubject Variability of Two Ciclosporin Formulations, SangCyaTM and Neoral®
| Autor: | Canafax Dm, R. Levy, Uwe Christians, Philippe Pouletty, First Mr, E. C. Squiers, William Irish, Moran Hb |
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| Rok vydání: | 1999 |
| Předmět: | |
| Zdroj: | Pharmacology. 59:78-88 |
| ISSN: | 1423-0313 0031-7012 |
| DOI: | 10.1159/000028307 |
| Popis: | A novel bioequivalence testing approach was used to determine intrasubject variability and switchability of two ciclosporin formulations, SangCyaTM (test) and Neoral® (reference). Twenty healthy volunteers were enrolled into a single-dose, randomized, open-label, 4-period, 2-sequence study with a crossover replicate design. Subject-by-formulation interaction variances were compared using a mixed effects linear model. Intrasubject variability for ln AUC0–∞ and ln Cmax of SangCya and Neoral were not significantly different. The 95% confidence intervals of the intrasubject variability of AUC0–∞ (0.94) and Cmax (1.28) as determined using the bootstrap nonparametric percentile method (n = 2,000) were below the individual bioequivalence limit estimated at 2.25. We concluded equivalent intrasubject variability of ciclosporin pharmacokinetics and switchability between SangCya and Neoral. |
| Databáze: | OpenAIRE |
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