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  • 1
    Electronic Resource
    Electronic Resource
    Anxiety and depression in Taiwanese cancer patients with and without pain (2000)
    Oxford UK : Blackwell Science Ltd
    Journal of advanced nursing 32 (2000), S. 0 
    Details
    ISSN: 1365-2648
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Anxiety and depression in Taiwanese cancer patients with and without pain The purpose of this investigation was to compare anxiety and depression in Taiwanese cancer patients with and without pain. In 1998, a convenience sample of 203 hospitalized cancer patients, 77 with pain and 126 without pain, were assessed for anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Disease-related factors such as performance status, disease stage and perceived treatment effect were also assessed and controlled for their effect on anxiety and depression. The prevalence of both anxiety and depression in the pain group was significantly higher than that for the pain-free group. After controlling the effect of disease-related factors, patients’ pain status had a significant effect on depression, but not on anxiety. Patients with pain had more depressive symptoms than patients without pain. Cancer patients’ anxiety can be predicted significantly by functional status and perceived treatment effect. In addition to pain status, cancer patients’ depression can be predicted by their functional status.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2648.2000.t01-1-01560.x
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  • 2
    Electronic Resource
    Electronic Resource
    Development and testing of the Family Caregiving Consequences Inventory for home nursing assessment in Taiwan (1999)
    Oxford UK : Blackwell Science Ltd
    Journal of advanced nursing 30 (1999), S. 0 
    Details
    ISSN: 1365-2648
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Development and testing of the Family Caregiving Consequences Inventory for home nursing assessment in Taiwan This paper describes the development and psychometric testing of the Family Caregiving Consequences Inventory (FCCI). Data were collected from a convenience sample of 97 families in Taiwan to examine the validity and reliability of the three FCCI scales: frail elder outcomes, caregiver outcomes and family outcomes. Acceptable test–retest and internal consistency reliabilities were found, though inter-rater reliability was unsatisfactory. Criterion-related validity was demonstrated by congruence with home nursing specialists’ assessment of family caregiving outcomes. Confirmatory factor analysis with a good overall model fit supported the construct validity of FCCI. However, a poor fit of the internal measurement structure was found for the frail elder outcomes scale and the family outcome scale. Studies with larger samples are needed to further verify the measurement models used here. Nevertheless, in its current form, the FCCI can be used to increase the sensitivity of home care nurses to family caregiving situations and provide an instrument for studies of family caregiving in Taiwan and other countries with similar home care needs.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2648.1999.01136.x
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  • 3
    Electronic Resource
    Electronic Resource
    Validation of the structure of the perceived meanings of cancer pain inventory (1999)
    Oxford UK : Blackwell Science Ltd
    Journal of advanced nursing 30 (1999), S. 0 
    Details
    ISSN: 1365-2648
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Validation of the structure of the perceived meanings of cancer pain inventory This study examined the structure of a newly developed instrument measuring the meaning of cancer pain for Taiwanese patients. The Perceived Meanings of Cancer Pain Inventory (PMCPI) was developed based on Lazarus’s cognitive theory of emotion and on findings from qualitative interviews. The 27-item PMCPI contains six scales: loss, threat, challenge, blame-others, blame-self, and spiritual awareness. Two hundred cancer patients from three hospitals in northern Taiwan who were experiencing pain were included in the study. A series of confirmatory factor analyses were conducted to test the fit of specified measurement models. The results indicated that only the loss, threat, challenge and spiritual awareness scales possessed good construct validity, while blame-other and blame-self failed to show a satisfactory fit with the data. Correlation coefficients among the scales were also estimated. Parallel-item testing demonstrated that the items of each valid scale had the same factor loading and error variance.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2648.1999.01078.x
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  • 4
    Electronic Resource
    Electronic Resource
    Oral CD3-specific antibody suppresses autoimmune encephalomyelitis by inducing CD4 + CD25 − LAP + T cells (2006)
    [s.l.] : Nature Publishing Group
    Nature medicine 12 (2006), S. 627-635 
    Details
    ISSN: 1546-170X
    Source: Nature Archives 1869 - 2009
    Topics: Biology , Medicine
    Notes: [Auszug] A major goal of immunotherapy for autoimmune diseases and transplantation is induction of regulatory T cells that mediate immunologic tolerance. The mucosal immune system is unique, as tolerance is preferentially induced after exposure to antigen, and induction of regulatory T cells is a primary ...
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1038/nm1408
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  • 5
    Electronic Resource
    Electronic Resource
    Absorption Rate Vs. Exposure: Which Is More Useful for Bioequivalence Testing? (1996)
    Springer
    Pharmaceutical research 13 (1996), S. 453-456 
    Details
    ISSN: 1573-904X
    Keywords: absorption rate ; bioequivalence ; Cmax/AUClqc ; Cmax/ AUC ; exposure
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Purpose. The goals were to evaluate the usefulness of Cmax/AUClqc, ratio of the maximum plasma drug concentration to the area under the plasma concentration-time curve to the time of the last quantifiable concentration, in bioequivalence testing and to explore the use of exposure as a replacement for the concepts of rate and extent of drug absorption. Methods. The bioequivalence of products differing in both rate (ka) and extent (F) of absorption was assessed under conditions similar to those encountered in a typical trial. A one-compartment model drug with first-order absorption (rate constant = ka) and elimination was used. Variability was introduced in all model parameters using Monte Carlo techniques. The results were expressed in terms of the probability of declaring bioequivalence in a cross-over trial with 24 subjects using Cmax/AUClqc, AUClqc, and Cmax as bioequivalence measures. Results. The outcome of a bioequivalence trial was shown to depend on the measure. Cmax/AUClqc reflected changes in ka, but not in F. AUClqc showed dependence on F, but virtually no dependence on ka. For Cmax, a 3- to 4-fold increase in ka and a concomittant 20% decrease in F, as well as corresponding changes in the opposite directions, resulted in bioequivalent outcomes. Conclusions. It was concluded that use of Cmax/AUClqc should be discouraged and that defining bioequivalence in terms of rate and extent of absorption has major problems. The goal of bioequivalence trials should be to assure that the shape of the concentration-time curve of the test product is sufficiently similar to that of the reference product. To this end, the use of “exposure” rather than “rate and extent of absorption” concepts is encouraged.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1016061013606
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  • 6
    Electronic Resource
    Electronic Resource
    The Role of Metabolites in Bioequivalency Assessment. II. Drugs with Linear Pharmacokinetics and First-Pass Effect (1995)
    Springer
    Pharmaceutical research 12 (1995), S. 700-708 
    Details
    ISSN: 1573-904X
    Keywords: bioequivalence ; rate of absorption ; rate of availability ; parent drug ; metabolite ; linear pharmacokinetics ; first-pass
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Simulations were conducted to address the question of whether metabolite data are required for bioequivalence evaluation of immediate release formulations with drugs exhibiting linear pharmacokinetics and first-pass effect. Plasma level-time profiles were generated for parent drug and metabolite using relevant rate constants obtained from a bivariate normal distribution and designated random error. Simulation results showed that the need for metabolite data (Cmax) in the assessment of bioequivalence depends on the relative variability between the absorption process of the drug and first-pass route for metabolite(s). The importance of metabolite Cmax data in the evaluation of rate of availability is clearly demonstrated for drugs with a high degree of intra-subject variation in the first-pass metabolism compared to the absorption process of the drug. Under such conditions, a wider confidence interval was found for the metabolite rather than parent drug. Opposite results were obtained when the intra-subject variance was high for drug absorption relative to first-pass effect. Discrepancies were observed for the scenarios in which the elimination pathway of the metabolite is more variable than the absorption process of the drug. The simulation results were in agreement with real bioequivalence data. It is thus recommended that, in the absence of the information on the relative variability of absorption and first-pass process, both parent drug and metabolite data be included for documentation of bioequivalence, should the metabolite(s) play an important role in the determination of efficacy and safety of the drug.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1016259509257
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  • 7
    Electronic Resource
    Electronic Resource
    The Duration of Measuring Partial AUCs for the Assessment of Bioequivalence (1998)
    Springer
    Pharmaceutical research 15 (1998), S. 399-404 
    Details
    ISSN: 1573-904X
    Keywords: bioequivalence ; partial AUC ; absorption rate ; experimental design ; crossover trials
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Purpose. To determine favourable sampling conditions for assessing bioequivalence by the comparison of partial AUCs in the early phase of concentration-time profiles. Methods. Two-period crossover trials were simulated. They assumed a wide range of the ratios of absorption rate constants of the test (T) and reference (R) formulations (kaT/kaR). Averages and standard deviations of the corresponding ratios of simulated partial AUCs (AUCpT/AUCpR) were determined together with the statistical power of assessing bioequivalence, i.e., the percentage of simulated trials in which bioequivalence was declared. Results. The power for stating bioequivalence was high when AUCP was recorded until the earlier rather than the later of two peaks in each subject. Similarly, power was comparatively high when AUCP was measured until the time of the reference peak instead of multiples of this time. Power was high also when AUCp was determined until the fixed true, population mean time of the reference formulation instead of multiples of this time. The pattern for the kinetic sensitivity parallelled that found for the power, while the standard deviations changed generally in the opposite direction. Conclusions. The effectiveness (power) of evaluating bioequivalence in the early phase of concentration-time profiles by partial AUCs generally decreases when the duration for measuring the metric is extended. Among the investigated designs, determination of partial AUCs until the earlier of two peaks in each subject is the most powerful.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1011916113082
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  • 8
    Electronic Resource
    Electronic Resource
    Bioequivalence: Performance of Several Measures of Extent of Absorption (1994)
    Springer
    Pharmaceutical research 11 (1994), S. 715-722 
    Details
    ISSN: 1573-904X
    Keywords: pharmacokinetics ; bioequivalence ; extent of absorption ; power analysis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The determination of the area under the concentration–time curve (AUC) is the method most commonly used by regulatory agencies to assess extent of drug absorption after single-dose administration of oral products. Using simulations, several approaches toward measuring the actual area, in whole or part, were tested. In addition, the performance of the peak concentration (C max), usually taken as a measure of the rate of absorption was assessed evaluating extent. Model scenarios for drugs with typical mean characteristics and statistical distributions were investigated. Using different kinetic models of disposition, the time course of the drug concentration in plasma was simulated. Intraindividual and interindividual variability and assay error were modeled using Monte Carlo techniques. The accuracy, precision, and ease of use of the various measures of extent were evaluated, and statistical power analyses were performed. Among the measures tested, the most reliable were the AUC computed up to the time of the last quantifiable concentration, without extrapolation, and C max. However, being also sensitive to rate, C max as a measure of extent is of limited potential.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1018932430733
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  • 9
    Electronic Resource
    Electronic Resource
    Bioequivalence: Performance of Several Measures of Rate of Absorption (1994)
    Springer
    Pharmaceutical research 11 (1994), S. 966-974 
    Details
    ISSN: 1573-904X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The highest point of the plasma concentration-time profile, C max , is currently used by regulatory agencies to assess the rate of drug absorption after single dose administration of oral products. It is, however, quite insensitive, and a number of new measures of rate have been proposed. Using simulations, several approaches toward measuring rate were tested. A set of model scenarios for drugs with typical mean characteristics and statistical distributions was investigated. Using different kinetic models of disposition, the time course of the concentration in plasma was simulated. Intraindividual and interindividual variability and assay error were modeled using Monte Carlo techniques. The accuracy, precision, and ease of use of the various measures of rate were evaluated by simulating crossover design clinical trials and then determining the probability of declaring bioequivalence as a function of differences in rates of absorption between test and reference formulations. All of the rate measures tested showed a degree of insensitivity to changes in rate and no universally superior measure was found. Indeed, the main conclusion is that the choice of a measure should be based on simulations of the particular situation in a bioequivalence trials.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1018970901116
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  • 10
    Electronic Resource
    Electronic Resource
    Metrics Comparing Simulated Early Concentration Profiles for the Determination of Bioequivalence (1998)
    Springer
    Pharmaceutical research 15 (1998), S. 1292-1299 
    Details
    ISSN: 1573-904X
    Keywords: bioequivalence ; intercept metric ; early exposure ; absorption rate ; partial AUC ; experimental design
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Purpose. To compare the effectiveness of various metrics which evaluate bioequivalence in the early phase of concentration-time profiles. Methods. Two-period crossover trials were simulated with increasing assumed ratios of the true absorption rate constants of the two formulations, and with various kinetic models. Kinetic sensitivities (KS) and standard errors (SE) of the various metrics were recorded and the percentage of trials accepting bioequivalence (the statistical power) was evaluated. The principal metrics included the partial AUC (AUC P) the intercept obtained by linear extrapolation of the ratios of the lower over higher concentrations (C) measured for the two formulations (I L /H), and the ratios of intercepts extrapolated from logarithmic C/ time values of the two products (M log). For comparison, also properties of C maxand an ideally evaluated measure (Id) were determined. Results. M logshowed generally the highest statistical power and KS, and also the largest SE, closely followed by I L /H. Partial AUC exhibited lower power and KS, but also smaller SE than the intercept procedures. The three methods had much higher power, KS and SE than C max. These comparisons were maintained over various kinetic conditions and experimental designs. The effective evaluation of bioequivalence in the early phase of studies is assured with 3 (or more) measurements until the population average peak of the reference formulation. Conclusions. The three principal methods assess bioequivalence very effectively in the early phase of a concentration-time profile. M loghad the highest statistical power, closely followed by IL /Hand then by partial AUC.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1011912512966
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