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In this paper a new method for the assessment of both individual and population bioequivalence is proposed that is derived from the approach of Schall and Luus (1993, Statistics in Medicine 12, 1109-1124). The method considers the probability that the bioavailability of the test product is close to the bioavailability of the reference product, against the(More)
Bioequivalence studies are generally performed as crossover studies and, therefore, information on the intrasubject coefficient of variation is needed for sample size planning. Unfortunately, this information is usually not presented in publications on bioequivalence studies, and only the pooled inter- and intrasubject coefficient of variation for either(More)
BACKGROUND AND PURPOSE Determining the functional/health status of stroke survivors poses special difficulties because of cognitive impairments that frequently result from stroke. A possible means of assessing the status of stroke survivors who are cognitively impaired is getting proxy responses from a family member or other caregiver. Proxy agreement was(More)
BACKGROUND New antituberculosis regimens are urgently needed to shorten tuberculosis treatment. Following on from favourable assessment in a 2 week study, we investigated a novel regimen for efficacy and safety in drug-susceptible and multidrug-resistant (MDR) tuberculosis during the first 8 weeks of treatment. METHODS We did this phase 2b study of(More)
The effect of the hemispace in which writing was performed was assessed in two left hemisphere stroke patients who demonstrated left-handed mirror writing. Both patients produced significantly more mirrored words when writing in right, as compared to left (body) hemispace. We suggest that writing in the right hemispace activates the left hemisphere.(More)
For market approval, new drug formulations (test) must demonstrate bioequivalence (BE) to at least one approved formulation (reference). If several formulations of a drug are already on the market, one might have to show BE to more than one reference formulation. Similarly, if several test formulations have shown BE to a reference formulation, it will be of(More)
Bioequivalence of two drug formulations is currently defined by drug regulatory authorities in terms of the mean responses following administration of the test and reference formulations (average bioequivalence). However, the various potential shortcomings of average bioequivalence are now understood, and switchability, and thus individual bioequivalence,(More)
Data on a twice-daily dosage schedule with moclobemide in the treatment of depression is limited. In this study, moclobemide 150 mg twice daily (b.i.d.) was compared to two different three-times-daily (t.i.d.) regimens with total daily dosages of 300 and 450 mg, respectively, over a 6-week period. The study was randomized, double-blind, and conducted at(More)
We investigate mixed models for repeated measures data from cross-over studies in general, but in particular for data from thorough QT studies. We extend both the conventional random effects model and the saturated covariance model for univariate cross-over data to repeated measures cross-over (RMC) data; the resulting models we call the RMC model and(More)
Least squares regression based on probability plots, also called rank regression, can be used to estimate the parameters of some distributions. Regression is performed between a function of the empirical distribution function and the order statistic as the independent variable. Using large sample properties of the empirical distribution function and order(More)