Introduction: Quality improvement (QI) is a major focus of all departments and fields of health care, including emergency medical services. The chaotic and rapidly evolving atmosphere in which paramedics must practice can lead to inconsistency between what is documented and the actual events. This leads to difficulty when trying to evaluate the practitioners and when implementing a QI program.
View Article and Find Full Text PDFThe paper investigates the assumed ideological divide between cosmopolitans and communitarians as part of a new globalisation-related cleavage in Europe. First, the central values and attitudes that form the foundation of the ideological divide are identified. Then, a new methodological approach is proposed, in order to identify the ideological divide using two different classification approaches.
View Article and Find Full Text PDFObjectives: Peripherally directed treatments (targeted exercise, surgery) can reduce, but not fully eliminate, pain for up to 40% of patients with Achilles tendinopathy. The objectives of the present study were (1) to identify indicators of altered central processing in participants with Achilles tendinopathy compared to controls, and (2) to determine which indicators of altered central processing would persist after a local anesthetic injection in patients with Achilles tendinopathy.
Design: Mechanistic clinical trial.
Most nonoperative treatments for insertional Achilles tendinopathy (IAT) have insufficient evidence to support treatment recommendations. Exercise has the highest level of evidence supporting the ability of this treatment option to reduce IAT pain. The effects of exercise may be enhanced by a wide variety of other treatments, including soft tissue treatment, nutritional supplements, iontophoresis, education, stretching, and heel lifts.
View Article and Find Full Text PDFWe carried out a multidisciplinary study linking behavioral and morphological data from a little-known guenon species, Cercopithecus solatus, endemic to Gabon. Over a period of 9 months, we documented the pattern of stratum use associated with postural and locomotor behavior by direct observation (650 hrs) of a semi-free-ranging breeding colony. We also conducted a morphometric analysis of the humerus and limb proportions of 90 adult specimens from 16 guenon species, including C.
View Article and Find Full Text PDFAn open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.
View Article and Find Full Text PDFThe Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters.
View Article and Find Full Text PDFBackground: Cardiac arrest center (CAC) criteria are not well defined, nor is their potential impact on current emergency medical services (EMS) transportation practices for post-cardiac arrest (PCA) patients. In addition to the availability of emergent cardiac catheterization (CATH) and therapeutic hypothermia (TH), high-volume centers and those with PCA protocols have been associated with improved outcomes. Objectives.
View Article and Find Full Text PDFThe aim of the present study was to compare the bioavailability of doxycycline (CAS 564-25-0) from two different doxycycline hyclate (CAS 24390-14-5) capsules (Monodoks 100 mg capsule as test preparation and 100 mg capsule of the originator product as reference preparation) in 24 healthy male subjects. The study was conducted according to an open-label, randomised two-period cross-over design with a wash-out phase of 16 days. Blood samples for pharmacokinetic profiling were taken up to 72 h post-dose, and doxycycline plasma concentrations were determined with a validated HPLC method with UV-detection.
View Article and Find Full Text PDFArzneimittelforschung
November 1998
An investigation of the bioequivalence of a new tablet formulation (amitriptylin 25 von ct) with 28.3 mg amitriptyline hydrochloride (CAS 549-18-8) was performed in a two-way cross-over study with 18 subjects. The relative bioavailability with respect to a reference preparation for AUC related to amitriptyline (CAS 50-48-6) was 99.
View Article and Find Full Text PDFThe safety, tolerability and pharmacokinetics of DW-116, a new fluoroquinolone with a broad antibacterial spectrum, were evaluated in healthy male subjects after administration of single oral doses of 100, 200, 300 and 800 mg and after administration of multiple oral doses of 300 or 400 mg, respectively, for 7 days. DW-116 was well tolerated. Gastrointestinal symptoms and skin reactions were noted and considered to be possibly related to DW-116.
View Article and Find Full Text PDFSustained release theophylline (CAS 58-55-9) preparations may be dosed once or alternatively twice-a-day, depending on the intention of a theophylline therapy. A once-a-day dosage regimen is considered appropriate in patients with nocturnal asthma attacks, whereas a twice-a-day regimen is advantageous for guaranteeing bronchodilatation and to control the underlying inflammatory disease. Therefore, pharmacokinetic characteristics of both modes of administration were evaluated in a randomised, two-way crossover study in 18 female and male elderly volunteers under multiple-dose conditions.
View Article and Find Full Text PDFEspecially in drugs with a narrow therapeutic range, "within product bioequivalence" i.e. "batch-to-batch bioequivalence" should be scrutinized.
View Article and Find Full Text PDFThe study objective was to obtain detailed information on the bioavailability and pharmacokinetics of the new fixed combination of delapril and indapamide following single and multiple dosing. For this reason, the study was performed in two parts, separated by a medication-free period of at least 7 days. In the single dose part, one tablet, containing 30 mg delapril and 2.
View Article and Find Full Text PDFEur J Drug Metab Pharmacokinet
May 1994
The aim of the study presented here was to determine possible pharmacokinetic interactions of moxonidine and glibenclamide at steady state in 18 healthy male volunteers. Multiple oral doses of 0.2 mg of moxonidine b.
View Article and Find Full Text PDFThe study objective was to obtain detailed information on the plasma and urine kinetics of amitriptylinoxide (CAS 4317-14-0) and its metabolites. For this reason, 60 mg of amitriptylinoxide was administered to 12 subjects, both by intravenous infusion and by oral dosage, in a study performed according to a randomized two-way cross-over design. In plasma, we succeeded in analyzing the metabolites amitriptyline and nortriptyline in addition to the parent substance amitriptyloxide.
View Article and Find Full Text PDFTwo different single dose cross-over bioavailability studies were performed comparing a new oral furosemide preparation (test preparation = preparation A) with a marketed standard with a marketed standard preparation (reference preparation = preparation B). Test and reference preparation contained 40 mg of furosemide each. Into both studies, 18 healthy male volunteers were included; 4 volunteers participated in both studies.
View Article and Find Full Text PDFA glibenclamide preparation (Glycolande N) with a modified galenic formulation was compared with a marketed standard preparation for bioequivalence and hypoglycaemic action after single oral administration of 3.5 mg. Twelve healthy male volunteers participated in this open two-way cross-over study.
View Article and Find Full Text PDFThe efficacy and safety of urapidil has been demonstrated in a long-term treatment. However, a relatively good record of side effects has been marred by reports of orthostatic dysregulation. This study was designed to examine the blood pressure lowering effect, tolerability and pharmacokinetics of a sustained-release formulation of urapidil.
View Article and Find Full Text PDFIn the course of this trial the bioavailability and the essential pharmacokinetic parameters of a newly developed 10 mg nifedipine preparation were to be determined in comparison to a marketed reference preparation after single oral administration. For this purpose, the test and the reference preparation were examined in 16 healthy volunteers according to a randomized 2-way cross-over design (latin square), blood samples were withdrawn up to 16 h p.a.
View Article and Find Full Text PDFA specific and sensitive high-performance liquid chromatographic method for the quantitative analysis of verapamil and N-desmethylverapamil in human serum is described. The analytes were extracted from serum using diethylether under alkaline conditions, followed by back extraction into dilute hydrochlorid acid for chromatographic analysis on a reversed-phase column with a mobile phase consisting of acetonitrile, water and perchloric acid at a flow rate of 1 l/min. The analytes were detected by fluorescence detection, the influence of temperature on retention is discussed.
View Article and Find Full Text PDFArzneimittelforschung
October 1988
An improved high performance liquid chromatographic (HPLC) assay for the quantitative determination of trans-doxepin (I) and desmethyldoxepin (II) in body fluids is presented. This HPLC assay, employing a UV-detector and perazine (III) as an internal standard, provides a very sensitive and selective determination in the low ng/ml range. The lower limit of quantification was 0.
View Article and Find Full Text PDFArzneimittelforschung
October 1988
The problem of accurate determination of tiotixene in body fluids is still challenging. Several methods have been published but most of them require a tedious, time-consuming sample preparation, are not specific enough and lack the necessary sensitivity or require highly sophisticated analytical devices. As carefully validated analytical methods represent the basis of conclusive clinical trials (e.
View Article and Find Full Text PDF