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  • 1
    Electronic Resource
    Electronic Resource
    Dose Proportionality and Population Characteristics of Oral Fadrozole Hydrochloride, an Aromatase Inhibitor, in Postmenopausal Women (1993)
    Springer
    Pharmaceutical research 10 (1993), S. 1760-1764 
    Details
    ISSN: 1573-904X
    Keywords: fadrozole hydrochloride ; linear pharmacokinetics ; population components of variance
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The dose proportionality of the pharmacokinetics of fadrozole was investigated in 18 healthy postmenopausal women. Fadrozole hydrochloride was administered as 0.3-, 1.0-, and 2.0-mg oral doses continuously every 12 hr for 5 days each in a Latin square design. At steady state, the dose-normalized pharmacokinetic parameters AUC and C max were found to be independent of the dose. In addition, no statistically significant differences in t max were detected. It was concluded that the pharmacokinetics of fadrozole were dose proportional in the projected therapeutic dose range. The relationship between oral clearance and the demographic factors, age, weight, and height, was assessed. Oral clearance was related to total body weight but not age or height. Prospective estimates of the population components of variance showed that intersubject variance accounted for 91.7% of the total random variance. Weight variance accounted for 36.1% of the intersubject variance.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1018930316215
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Pharmacokinetic Disposition of Multiple-Dose Transdermal Nicotine in Healthy Adult Smokers (1992)
    Springer
    Pharmaceutical research 9 (1992), S. 1451-1455 
    Details
    ISSN: 1573-904X
    Keywords: Nicotine TTS ; transdermal pharmacokinetics and pharmacodynamics ; components of variance
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The pharmacokinetics and cardiovascular effects of nicotine and its major metabolite, cotinine, were characterized during repeated once-daily application for 5 days of a 30-cm2 nicotine transdermal system, Nicotine TTS (Habitrol), to nine healthy, black, adult, male smokers. Subjects abstained from smoking throughout the study. Pharmacokinetic analysis indicated that nicotine was delivered from Nicotine TTS for the 24-hr application period averaging 0.76 mg/ cm2/24 hr, and at a relatively constant rate compared to other modes of drug administration. The transdermal clearance of nicotine, 1351 ml/min, coincided with reported values following intravenous nicotine administration; however, the terminal-phase half-life, 5.0 hr, did not. An analysis of the components of variance contributing to the variability in nicotine delivery from repetitive application of Nicotine TTS indicated that the in vivo transdermal permeation of nicotine is rate limited by both the device and the intrinsic skin conductivity. Clinical cardiovascular side effects were negligible as an apparent result of subclinical vasopressive nicotine concentrations, although drug activity with regard to other effects was manifested.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1015862930096
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    Paper (German National Licenses)
    Fulltext
  • 3
    Electronic Resource
    Electronic Resource
    Intra- and Intersubject Variability: Mixed-Effects Statistical Analysis of Repeated Doses of an Angiotensin Converting Enzyme Inhibitor, CGS 16617 (1989)
    Springer
    Pharmaceutical research 6 (1989), S. 328-331 
    Details
    ISSN: 1573-904X
    Keywords: random-effects statistical model ; bioavailability trials ; biological variation ; intersubject variability ; intrasubject variability ; CGS 16617
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract 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.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1015954609527
    Library Location Call Number Volume/Issue/Year Availability
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    Paper (German National Licenses)
    Fulltext
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