| Autor: |
Van Wart SA; Cognigen Corporation, 395 Youngs Road, Buffalo, NY 14221, USA. scott.vanwart@cognigencorp.com, Cirincione BB, Ludwig EA, Meagher AK, Korth-Bradley JM, Owen JS |
| Jazyk: |
angličtina |
| Zdroj: |
Journal of clinical pharmacology [J Clin Pharmacol] 2007 Jun; Vol. 47 (6), pp. 727-37. |
| DOI: |
10.1177/0091270007300263 |
| Abstrakt: |
Tigecycline, a novel glycylcycline, possesses broad-spectrum antimicrobial activity. A structural population pharmacokinetic model for tigecycline was developed based on data pooled from 5 phase I studies. Intravenous tigecycline was administered as single (12.5-300 mg) or multiple (25-100 mg) doses every 12 hours for up to 10 days. Three-compartment models with zero-order input and first-order elimination separately described the single- or multiple-dose full-profile data. Additional models were evaluated using a subset of the phase I data mimicking the phase II/III trial sparse-sampling scheme and dosage. A 2-compartment model best described the reduced phase I data following single or multiple doses and provided reliably accurate estimates of tigecycline AUC(0-12). This modeling supported phase II/III population pharmacokinetic model development to further determine individual patient tigecycline exposures for safety and efficacy analyses. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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