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Editor’s Choice : Comparison of Outlier Detection Methods in Crossover Design Bioequivalence Studies
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Abstract: The significance of bioequivalence (BE) studies is rising due to large scale production and utilization of generic products all over the world. The correct identification of outlying data in BE studies is substantial for deciding two products either bioequivalence or bioinequivalent. For the detection of outliers in BE studies with the crossover designs different methods have been suggested in the literature. In the present work, we compared three outlier detection tests; (i) the Likelihood distance (LD) test (ii) the estimated distance (ED) test and the principal component analysis (PCA) test. In this work, the PCA test has been first time compared with the LD and ED test. For the purpose of comparison, we used two-way and three-way BE crossover data sets on linear and logarithmic scales. During the course of work it was found interesting and note-worthy that the performances of the ED and PCA tests in the sense of outlier detection are better than the LD test and this performance persists even for the log-transformed data. The results of our simulation study also indicated that the performance of the ED test for outliers’ identification is better than the other two tests. Keywords: Bioequivalence, Outliers, Likelihood distance, Estimated distance, Principal, Component.Download Full Article |
Editor’s Choice : Determination of Ground Water Quality for Agriculture and Drinking Purpose in Sindh, Pakistan
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Abstract: The study was conducted to assess the quality of ground water from different Talukas of district Tando Muhammad Khan for drinking and agriculture purpose. Water samples for determining the water quality were collected in one liter polyethylene bags by observing standard sample collection method. It was ensured that sample collection sites must be at least 500 feet away from each other.Physical and chemical parameters of ground and surface water samples such as pH, Electrical Conductivity (EC), Turbidity, Colour, Taste, Odour, Alkalinity as CaCO3, Bicarbonate (HCO3), Carbonate (CO3), Calcium (Ca), Magnesium (Mg), Hardness, Sodium (Na), Potassium (K), Chloride (Cl), Phosphate (PO4), Total Dissolved Solids (TDS) and Arsenic (As) were determined. The study clarified that pH and odour was within the permissible limits in majority of samples whereas, Arsenic (As),Hardness, Sodium (Na),Total Dissolved Solids (TDS), Taste, Chloride (Cl) and turbidity were beyond the permissible limits set by WHO. The groundwater status in Tando Muhammad Khan district, TDS in 50% samples, Chloride in 54.16% samples, Sulphate in 44.8% samples, Calcium in 38.5% samples, Sodium in 54.16% samples, hardness in 21.88% samples were beyond the WHO’s permissible limits for human consumption. Keywords: Ground water, physical composition, chemical composition.Download Full Article |
Editor’s Choice : Effect of Short Term Sibutramine Supplementation on Appetite Suppression and Related Metabolic Responses
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Abstract: The appetite suppressing property of Sibutramine is well reported. The present study was undertaken to investigate the appetite regulatory mechanism and associated metabolic changes induced in male Sprague Dawley rats by its short term supplementation. The effect of the drug on the regulatory hormones and biochemical variables was studied at an oral dose of 10 mg/kg body weight. There was a decrease in food intake of rats by 35.5% in comparison to their basal food intake as well as untreated controls. There was an increase in plasma levels of adiponectin, serotonin and a decrease in IGF-1 and corticosterone in the treated animals. The circulating levels of ghrelin marginally decreased with a corresponding increase in leptin and CCK in case of treated rats. These may be responsible for the anorectic effect of the drug. Keywords: Sibutramine hydrochloride monohydrate, obesity, appetite, leptin, ghrelin, adiponectin.Download Full Article |
Editor’s Choice : Effect of Grape Seed Extract on Blood Pressure in Subjects with Pre-Hypertension
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Abstract: Pre-hypertension affects approximately 31% of the adult population of the United States over the age of 18 years. It is defined in the 7th report of the Joint National Committee (JNC - 7) on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure as a systolic blood pressure of 120-139 mmHg or a diastolic blood pressure of 80-89 mmHg. JNC-7 also recommended that individuals considered to be prehypertensive require health-promoting lifestyle modifications to prevent cardiovascular disease. This study was undertaken to determine whether a grape seed extract (GSE) which is a nutraceutical containing vasodilator phenolic compounds lowers blood pressure in subjects with pre-hypertension. The subjects were randomized into a placebo or an experimental group (GSE at a dose of 300 mg/day) and treated for 8 weeks. Serum lipids and blood glucose were measured at the beginning of the study and at the end. The blood pressure was recorded using an ambulatory monitoring device at the start of the treatment period and at the end. Both the systolic and diastolic blood pressures were significantly lower after treatment with GSE. Treatment with the placebo had no effect on blood pressure. There were no significant changes in serum lipids or blood glucose values. These findings suggest that GSE could be used as a nutraceutical in a lifestyle modification program for patients with pre-hypertension. Keywords: Grape seed extract, pre-hypertension, human, polyphenolics.Download Full Article |
Editor’s Choice : Evaluation of Supplementation of Bittergourd Fermented Beverage to Diabetic Subjects
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Abstract: Diabetes mellitus is a chronic endocrine diseased condition reflected by higher level of blood glucose which is due to less insulin production, insulin action or both. Bittergourd juice consumption is being traditionally practiced for the treatment of diabetes mellitus in developing country such as India, but not supported through clinical data and highly bitter juice is difficult to drink. Therefore bittergourd fermented beverage with improved nutritional strength and taste was developed and supplemented to diabetic subjects and the evaluation was carried out. The evaluation of the bittergourd fermented beverage, in the first stage was carried out by supplementing the beverage to 30 diabetic subjects as an early morning drink in fasting conditionand the control group was asked to drink water. The fasting and post prandial blood sugar levels were studied and diabetic symptoms were noted. The impact of supplementation of bittergourd fermented beverage on diabetic subjects showed that subjects had significant improvement in reducing the symptoms of diabetes, as well reduced the fasting and post prandial glucose levels by 31% and 25% respectively when compared with the control group. Further 16 diabetic subjects who expressed their consent were given the bittergourd fermented beverage for a period of 5 months and the results of the long duration supplementaion indicated that there was a reduction of fasting blood glucose by 43% and post prandial blood glucose by 41% reflecting advantage of continued consumption of the beverage. In order to understand the direct action of the beverage on blood lipid profile–serum cholesterol, triglycerides, low density lipoprotein cholesterol, high density lipoprotein cholesterol as measured before and after supplementation showed the changes by 4-7% which is not considerable. However the glycoslated haemoglobin indicated encouraging results after the supplementation showing good control from fair control. Therefore, the study clearly reflected the positive effect of bittergourd fermented beverage in reducing and controlling blood sugar levels. Keywords: Bittergourd fermented beverage, diabetes, supplementation, biochemical parameters.Download Full Article |