European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Oct 2002
A simultaneous oral/intravenous population pharmacokinetic model for vinorelbine.
To develop a population pharmacokinetic (PK) model for simultaneous analysis of oral and intravenous data, to compare the variability between the two routes of administration of vinorelbine, to search for the main patient characteristics that explain this variability, and to estimate the mean population bioavailability of oral vinorelbine. ⋯ By means of the simultaneous analysis of oral and intravenous data the bioavailability (F=36%) and its associated variability were estimated. At usual doses similar levels of variability were observed between oral and intravenous routes. As a result of the identification of covariates from phase I data and their confirmation from phase II data further explorations based on limited sampling strategies are now possible. The use of a simultaneous oral/intravenous model allows a better characterization of the PK profile of vinorelbine after administration by either vascular or oral route
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Eur. J. Clin. Pharmacol. · Sep 2002
Randomized Controlled Trial Comparative Study Clinical TrialIbuprofen arginate provides effective relief from postoperative dental pain with a more rapid onset of action than ibuprofen.
Ibuprofen is a safe and effective analgesic, but some formulations have a slow onset of action. Ibuprofen arginate is a rapidly absorbed salt designed to promote more rapid onset of analgesia. A clinical trial was conducted in 226 patients with postoperative dental pain to assess the analgesic efficacy and speed of onset of the arginine salt of ibuprofen compared with one of the commercially available forms of ibuprofen. ⋯ Mean plasma ibuprofen concentrations at 30 min and 60 min, respectively, were: ibuprofen arginine 200 mg, 13.9 micro g/ml and 15.7 micro g/ml; ibuprofen arginine 400 mg, 29.5 micro g/ml and 29.3 micro g/ml; ibuprofen 200 mg 2.5 micro g/ml and 5 micro g/ml; ibuprofen 400 mg, 2.3 micro g/ml and 7.4 micro g/ml. ( P<0.05). Adverse event profiles were similar across treatment groups. These results overall suggest that ibuprofen arginate when taken at doses equivalent to commercially available ibuprofen formulations produces analgesia that is faster in onset.
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Eur. J. Clin. Pharmacol. · Jul 2002
ReviewMicrodialysis: an in vivo approach for measuring drug delivery in oncology.
Microdialysis (MD) is a catheter-based sampling method that provides the opportunity to directly study tumor drug exposure and metabolism in a minimally invasive way. Tumor drug exposure, which is directly linked to clinical outcome, may be substantially reduced due to diffusion barriers in solid tumors. ⋯ This contribution focuses on the application of MD in preclinical and clinical oncological research and presents an overview of the current literature. It is concluded that MD, in combination with pharmacokinetic/pharmacodynamic modeling, has the potential to contribute to the design of optimal treatment schedules and to select appropriate drug candidates, doses, and dosing intervals for established and new anticancer drugs.
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Eur. J. Clin. Pharmacol. · Jul 2002
Admissions caused by adverse drug events to internal medicine and emergency departments in hospitals: a longitudinal population-based study.
To estimate incidence rates of drug-related hospitalizations (DRHs) in a longitudinal population-based study with prospective event assessment. ⋯ DRHs are a considerable public health and economic burden. A longitudinal design can observe changes in population-based incidence over time. This approach can be used for public-health planning or to evaluate outcomes of quality management programs designed to reduce drug-induced illness.
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Eur. J. Clin. Pharmacol. · Jun 2002
Comparative StudyQuality of non-steroidal anti-inflammatory drug prescribing in Croatia (Rijeka) and Sweden (Stockholm).
We compared the utilisation pattern and cost of non-steroidal anti-inflammatory drugs (NSAIDs) in Rijeka, Croatia and in Stockholm, Sweden using a newly introduced method for assessing the quality of drug use, i.e. to determine the number of drugs that account for 90% of the use and the adherence to evidence-based recommendations within this segment (the DU90% methodology). ⋯ Our study suggests that evidence-based medicine was not the leading impact factor in prescribing NSAIDs during 2000. A proportionally higher use of ibuprofen (at a daily dose of 1200 mg) and a reduced use of either piroxicam or ketoprofen would improve the NSAID GI safety profile in both countries. As previously shown for Sweden and some other countries, the DU90% methodology was found to be a useful method for assessing the general quality of NSAID prescribing in Croatia.