The aim of this work is to evaluate average bioequivalence (ABE) and population bioequivalence (PBE) statistical approaches so as to identify which approach is most suitable for
in vitro
...bioequivalence (IVBE) testing of nasal spray products. For droplet size distribution (DSD) and spray pattern (SP),
in vitro
data were collected using a well-established nasal spray on the market (Nasonex®, manufactured by Merck Sharp & Dohme Limited). Simulations were performed using
in vitro
data to comparatively investigate ABE and PBE tests. For highly variable parameters such as SP area, this study clearly demonstrates that the level of agreement between ABE and PBE test conclusions is much smaller as compared with that of DSD Dv(50), which was found to have moderate variability. PBE approach dictates equivalence for both means and variances, and was found to handle both SP and DSD parameters with similar passing rates compared to the passing rates from the ABE approach. However, pronounced asymmetric behavior of PBE empirical power curves for highly variable SP area was observed. A modified PBE statistical approach is proposed for DSD span and Dv(50)
in vitro
parameters, where acceptance criteria would be based on comparison of reference/branded product to itself as part of “pre-IVBE study”
via
innovative statistical bootstrap simulations. Due to inherent high variability of the SP area parameter driving pronounced asymmetric behavior of PBE power curves, and due to unclear
in vivo
relevance for SP area and ovality, authors propose that SP parameters be used as development and quality control tools rather than for demonstration of IVBE.
Several factors have been shown to affect psoriasis pathogenesis, clinical presentation and treatment response.
The aim of this study was to investigate the potential relationship between patients' ...baseline characteristics and the efficacy of calcipotriol-betamethasone ointment in patients with mild to moderate plaque psoriasis and to evaluate whether the efficacy is consistent across subgroups.
Using data from the therapeutic equivalence study on patients with plaque psoriasis, post hoc analyses were performed to evaluate the impact of baseline demographic and disease characteristics, habits and comorbidities on the response to treatment with calcipotriol-betamethasone ointment.
Body mass index (BMI) and obesity were each independently associated (univariate analysis, p < 0.05) with reduction in modified Psoriasis Area and Severity Index (mPASI) and PASI75 (≥75% improvement in mPASI from baseline). Increased body weight is more common in patients with late-onset psoriasis. There was a significant trend for lower response rates with increasing BMI (p = 0.007) and obesity (p = 0.003). The odds of achieving PASI75 is 2.3 times lower for obese compared to normal-weight subjects.If patients with obesity or hypertension were treated with calcipotriol-betamethasone, they were still more likely to achieve PASI75 after 4-week treatment compared to vehicle (p < 0.001).
Increased BMI and obesity present risk factors for reduced treatment effectiveness. Importantly, the efficacy of calcipotriol-betamethasone ointment was consistent in all subgroups.
The goal of this paper is to demonstrate the analytical use of a statistical tool ANOM (more commonly used by quality control engineers), mixed model analysis and other statistical tools (used in ...social sciences) to investigate differences found in Croatian high school student performance in mathematics examinations, recently developed as part of the National Assessment project.
Equivalence testing the easy way LUZAR-STIFFLER, Vesna; STIFFLER, Charles
CIT. Journal of computing and information technology,
2002, Volume:
10, Issue:
3
Conference Proceeding, Journal Article, Paper
Peer reviewed
Open access
The purpose of the article is to demonstrate an equivalence testing software application written under SAS^1 Institute software designed for use by pharmaceutical and other medical research ...professionals. Besides making the entire equivalence testing procedure easier and more efficient, the application “EquivEasy” offers three main advantages over similar software: a) testing for 3 x 3 in addition to 2 x 2 crossover designs, b) familiar SAS user environment, and c) export flexibility (MS Word, PDF, HTML). Two case studies are presented with report results provided in tabular and graphical form.
The motivation for this research stemmed from a desire to create visual aids to help researchers/managers interpret ensembles of decision tree outputs generated by various algorithms. The method ...employed a simulation experiment (using only bagging) followed by application of the new visualization tools on actual survey data. Simulated data, with a prespecified structure, were "bagged" with the results presented using five graphical tools that recreated (and/or portrayed) the known data structures captured by the bagging algorithm. Then the same methodology was generalized to a structurally unknown, virgin (survey) data set. Results of the research are that five visual aids tools were examined (two of which are new approaches) and found to be useful for making action oriented interpretations from e.g., Web-survey data
Equivalence testing the easy way Luzar-Stiffler, V.; Stiffler, C.
ITI 2002. Proceedings of the 24th International Conference on Information Technology Interfaces (IEEE Cat. No.02EX534),
2002
Conference Proceeding
Open access
The purpose of the article is to demonstrate an equivalence testing software application written under SAS Institute software designed for use by pharmaceutical and other medical research ...professionals. Besides making the entire equivalence testing procedure easier and more efficient, the application "EquivEasy" offers three main advantages over similar software: (a) testing for 3/spl times/3 in addition to 2/spl times/2 crossover designs, (b) familiar SAS user environment, and (c) export flexibility (MS Word, PDF, HTML). Two case studies are presented with report results provided in tabular and graphical form.
A sample of 7000+ students was analyzed by the University Computing Centre (SRCE) staff to evaluate course satisfaction, teacher performance, and changing course demands. Findings indicated adequate ...overall performance, and changing course content needs over a four year time period. The major conclusion of the Project (SOCRATES) is that the software product developed during the research can become an economical and useful tool in helping to shape administrator efforts and decisions regarding the allocation of scarce organizational resources and in the development of new course offers at SRCE.
The goal of this paper is to demonstrate the analytical use of a statistical tool ANOM (more commonly used by quality control engineers), mixed model analysis and other statistical tools (used in ...social sciences) to investigate differences found in Croatian high school student performance on the mathematics examination, developed as part of the national assessment project.
The aim of the study was to examine the effect of birth weight, infant nutrition, body mass and social status from early childhood and adulthood on plasma lipid levels in 192 adult subjects examined ...in the first three years of life (mean age 1.4 years in males and 1.3 years in females) and again as adults (mean age 19.9 years in males and 19.6 in females). According to the results obtained, total cholesterol was significantly higher in adult male subjects breast fed for the shortest period of time (p < 0.05). Those males who were leanest in the first three years of life and fattest as adults had the highest levels of total cholesterol (p = 0.03) and LDL cholesterol (p = 0.02). Birth weight had no significant influence on plasma lipid levels in adults subjects. When data on nutrition, anthropometry and social status from both age periods were included in multivariate regression analyses, the most significant predictors of higher levels of total cholesterol and LDL cholesterol in males were lower adult height and poor social status in early childhood, while in females they were a shorter duration of breast feeding and earlier introduction of solids.
Preface Luzar-Stiffler, Vesna; Jarec, Iva
Proceedings of the ITI 2013 35th International Conference on Information Technology Interfaces,
2013-June
Conference Proceeding
Welcome to the Proceedings of the ITI 2013, 35th International Conference on Information Technology Interfaces.
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