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Multi-regional clinical trials have a hierarchical data structure because several regions form a patient population and individual patients are nested within their own regions. Data are obtained fr...

This paper proposes low-melting-point eutectic salts containing RbCl as electrolytes for light weight thermal batteries. The handleability of the eutectic salts was remarkably improved for commercialisation. Their performance as thermal battery molten-salt electrolytes was verified using tests on a single cell and a 12-cell stacked battery.

BACKGROUND AND OBJECTIVES The relationship between the hospital percutaneous coronary intervention (PCI) volumes and the in-hospital clinical outcomes of patients with acute myocardial infarction (AMI) remains the subject of debate. This study aimed to determine whether the in-hospital clinical outcomes of patients with AMI in Korea are significantly associated with hospital PCI volumes. METHODS We selected and analyzed 17,121 cases of AMI, that is, 8,839 cases of non-ST-segment elevation myocardial infarction and 8,282 cases of ST-segment elevation myocardial infarction, enrolled in the 2014 Korean percutaneous coronary intervention (K-PCI) registry. Patients were divided into 2 groups according to hospital annual PCI volume, that is, to a high-volume group (≥400/year) or a low-volume group (

One of the key issues in biosimilar phase III clinical trials is the determination of biosimilarity margins. Although biological products generally have high product variability, it is not reflecte...

The two-arm parallel design that is commonly used to assess biosimilarity has the drawback that it does not take into account the inherent variability within the reference products. The three-arm p...

Data observed in multiregional clinical trials are structurally hierarchical in the sense that the patient population consists of several regions and patients are nested within their own regions. T...

Biological products are known to have some between-batch variation. However, the traditional method to assess biosimilarity does not consider such between-batch variation. Beta-binomial mod...

Background: Cardiovascular risk remains increased despite optimal low density lipoprotein cholesterol (LDL-C) level induced by intensive statin therapy. Therefore, recent guidelines recommend non-high density lipoprotein cholesterol (non-HDL-C) as a secondary target for preventing cardiovascular events. The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (OM3-FAs) in combination with atorvastatin compared to atorvastatin alone in patients with mixed dyslipidemia. Methods: This randomized, double-blind, placebo-controlled, parallel-group, and phase III multicenter study included adults with fasting triglyceride (TG) levels ≥200 and

In this study, we fabricated a cathode with lower amounts of additive materials and higher amounts of active materials than those of a conventional cathode. A thermal battery was fabricated using FeS2 treated foam as the cathode frame, and its feasibility was verified. X-ray diffraction, transmission electron microscopy, and scanning electron microscopy were used to analyze the effects of thermal sulfidation temperature (400 and 500°C) on the structure and surface morphology of the FeS2 foam. The optimal temperature for the fabrication of the FeSx treated foam was determined to be 500°C. The FeS2 treated foam reduced the interfacial resistance and improved the mechanical strength of the cathode. The discharge capacity of the thermal battery using the FeS2 treated foam was about 1.3 times higher than that of a thermal battery using pure Fe metal foam.

The one of the principles described in ICH E9 is that only results obtained from pre-specified statistical methods in a protocol are regarded as confirmatory evidence. However, in multi-regional clinical trials, even when results obtained from pre-specified statistical methods in protocol are significant, it does not guarantee that the test treatment is approved by regional regulatory agencies. In other words, there is no so-called global approval, and each regional regulatory agency makes its own decision in the face of the same set of data from a multi-regional clinical trial. Under this situation, there are two natural methods a regional regulatory agency can use to estimate the treatment effect in a particular region. The first method is to use the overall treatment estimate, which is to extrapolate the overall result to the region of interest. The second method is to use regional treatment estimate. If the treatment effect is completely identical across all regions, it is obvious that the overall treatment estimator is more efficient than the regional treatment estimator. However, it is not possible to confirm statistically that the treatment effect is completely identical in all regions. Furthermore, some magnitude of regional differences within the range of clinical relevance may naturally exist for various reasons due to, for instance, intrinsic and extrinsic factors. Nevertheless, if the magnitude of regional differences is relatively small, a conventional method to estimate the treatment effect in the region of interest is to extrapolate the overall result to that region. The purpose of this paper is to investigate the effects produced by this type of extrapolation via estimations, followed by hypothesis testing of the treatment effect in the region of interest. This paper is written from the viewpoint of regional regulatory agencies.

Chitin and chitosan were extracted from all specimens of Type I and II two-spotted field crickets (Gryllus bimaculatus) following chemical treatment with an acid and alkali. For chitin extraction, 2 N HCl and 1.25 N NaOH solutions were used to achieve demineralization and deproteinization, respectively. For chitosan extraction, 50 % NaOH (w/v) and 50 % NaOH (w/w) solutions were used to achieve deacetylation. Chitosan yielded from adult exoskeletons of G. bimaculatus in Test A of Type I was 1.76 and 8.40 % on a fresh weight (FW) and dry weight (DW) basis, respectively, after treatment with 50 % NaOH (w/v) at 95°C for 3 h. Furthermore, the chitosan yielded in Test D of Type II was 1.79 and 7.06 % on FW and DW basis, respectively, after treatment with 50 % NaOH (w/w) at 105°C for 3 h. The average yield of chitin and chitosan was 2.42 and 1.65 % on a FW basis, and 10.91 and 7.50 % on DW basis, respectively. The deacetylation (%) of chitosan extracted from adult exoskeletons in Tests A, B, C1, C2, D1, and D2 were 81.2 %, 14.5 %, 19.6 %, 90.7 %, 17.1 %, and 95.5 %, respectively. The viscosities of the chitosans extracted from adult exoskeletons in Tests A, C2, and D2 were 32.0, 21.6, and 62.4 cP (centi Poise), respectively. The molecular weight of chitosan from adult exoskeletons of G. bimaculatus was 308.3 kDa. Our results indicate that adult exoskeletons of G. bimaculatus could be used as a source of chitin and chitosan for use as functional additives in industrial animal feeds.

A bioequivalence study is usually conducted with the same-day drug administration. However, hospitalization is occasionally separated for logistical, operational, or other reasons. Recently, there was a case of separate hospitalization because of difficulties in subject recruitment. This article suggests a better way of bioequivalence data analysis for the case of separate hospitalization. The key features are (1) considering the hospitalization date as a random effect than a fixed effect and 2) using "PROC MIXED" instead of "PROC GLM" to include incomplete subject data.

The use of a thermally and chemically stable ceramic felt separator for thermal batteries is believed to enhance the reliability by minimizing the sudden failure of an electrolyte upon shock compared to the conventional pellet-pressed one. To achieve desirable electrochemical properties for applications in thermal batteries, the separator should hold a sufficient amount of molten electrolyte with a minimal leakage to prevent physical contact between the cathode and anode. In addition, the chemical stability of the separator materials should be maintained under a very reactive molten Li-salt electrolyte environment to confer high ionic conductivity and reliability. To assess the feasibility of 3 types of ceramic felt as a separator for thermal batteries, 2 types of Al2O3 felt with different porosity and one ZrO2 felt are examined using binary LiCl-KCl and ternary LiF-LiCl-LiBr as the electrolytes. This Part 1 explains the wetting, loading and leakage behaviors of the ceramic felts for molten electrolytes along with the chemical stability. The ionic conductivity of the electrolytes and electrochemical properties of the resulting thermal batteries will be presented in Part 2.

In this Part 2, the ionic conductivity of molten salt electrolytes, the electrochemical properties of single cells containing a ceramic separator infiltrated with an electrolyte, and the mechanical strength of the electrolyte layer are compared with those of the conventional pellet-pressed structure. The ionic conductivity for the molten electrolyte is higher than that of the previous report for both LiCl-KCl and LiF-LiCl-LiBr electrolytes, which is explained by the decrease in contact resistance using a graphite electrode instead of stainless steel. The electrochemical performance of the single cells containing a ceramic felt separator assembled with Li(Si)/FeS2 electrodes shows longer operating time to a cut off voltage of 1.3 V compared to the conventional MgO-contained single cell. In addition, the flexural strength of the electrolyte layer with the ceramic felt separators is in the range of 2.80–6.29 kgf cm−2, which is incomparable to that (=0.01 kgf cm−2) of the pellet-pressed conventional separator. These findings suggest that the ceramic felt separator can be an alternative to mitigate the current problems of pellet-pressed structure in thermal batteries, enhancing the mechanical strength and electrochemical properties.

In this study, we fabricated a cathode with lower amounts of additive materials and higher amounts of active materials than those of a conventional cathode. A thermal battery was fabricated using FeS2 treated foam as the cathode frame, and its feasibility was verified. X-ray diffraction, transmission electron microscopy, and scanning electron microscopy were used to analyze the effects of thermal sulfidation temperature (400 and 500°C) on the structure and surface morphology of the FeS2 foam. The optimal temperature for the fabrication of the FeSx treated foam was determined to be 500°C. The FeS2 treated foam reduced the interfacial resistance and improved the mechanical strength of the cathode. The discharge capacity of the thermal battery using the FeS2 treated foam was about 1.3 times higher than that of a thermal battery using pure Fe metal foam.

In previous studies, we showed that the branch length similarity (BLS) entropy profile could be used successfully for the recognition of shapes such as battle tanks, facial expressions, and butterflies. In the present study, we introduce critical points defined as a set of distinguishing points with high curvature to the BLS entropy profile in order to improve the shape recognition. In order to generate a given number of critical points from the shape, we propose a critical point detection method. Furthermore, we show the invariant properties of the BLS entropy descriptor. To evaluate the effects of critical points on the shape recognition of the BLS entropy descriptor, we performed a butterfly classification experiment against a real image data set, and we conducted performance comparisons with other point detection methods. In addition, the performance of the BLS entropy descriptor computed using the critical points was compared with those of other well-known descriptors such as the Fourier descriptor using three machine learning techniques, the Bayesian classifier, the multi-layer perceptron and the support vector machine. The results show that the BLS entropy descriptor outperforms other well-known descriptors.

Chitins and chitosans are some of the most abundant natural polysaccharide materials, and are used to increase innate immune response and disease resistance in humans and animals. In this work, chitin and chitosan from housefly, Musca domestica, pupa shells were obtained by treatment with HCl and NaOH. For chitin extraction, 2 N HCl and 1.25 N NaOH solutions were used to achieve decalcification and deproteinization, respectively. For chitosan extraction, 50% NaOH solution was used to achieve deacetylation. The yields of chitin and chitosan from pupa shells of M. domestica were 8.02% and 5.87%, respectively. The deacetylations of chitosan (from chitin C1 and C2) were 89.76% and 92.39%, respectively, after the first alkali treatment with 50% NaOH (w/w) solution at 105 °C for 3 h and 5 h, respectively. The viscosities of the chitosans (from chitin C1 and C2) were 33.6 and 19.2 cP, respectively.