Autor: | R A Smith, J K deSilva, Vivian A. John, D J Weidler, V Tipnis, Frank Honc, Gregory M. Kochak, R L Choi |
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Rok vydání: | 1989 |
Předmět: |
Pharmacology
medicine.medical_specialty biology Chemistry Organic Chemistry Pharmaceutical Science Half-life Angiotensin-converting enzyme Bioavailability Endocrinology Pharmacokinetics Oral administration Enzyme inhibitor Biological variation Internal medicine medicine biology.protein Molecular Medicine Pharmacology (medical) Statistical analysis Biotechnology |
Zdroj: | Pharmaceutical Research. :328-331 |
ISSN: | 0724-8741 |
DOI: | 10.1023/a:1015954609527 |
Popis: | The intrasubject and intersubject variabilities for CGS 16617, an angiotensin converting enzyme inhibitor, were evaluated in an open-label, repeat single-dose bioavailability trial. Eight healthy male volunteers each received a 20-mg oral dose of CGS 16617 as an aqueous solution on four separate occasions. Components of variance were evaluated for a mixed-effects statistical model in which subjects were regarded as a random factor. While intersubject variability was statistically significant (P < 0.05) for all pharmacokinetic variables measured, AUC, C max, t 1/2, and t max, its contribution to the total observed variability was relatively small for AUC, t 1/2 and t max. The proportion of variation due to intrasubject variability was 70, 19, 61, and 72% for AUC, C max, t 1/2, and t max, respectively. Ramifications of the large intrasubject source component of variability as related to bioavailability trials and biological variation are discussed. |
Databáze: | OpenAIRE |
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