Comparison of Outlier Detection Methods in Crossover Design Bioequivalence Studies
– Pages 163-170
A. Rasheed1, T. Ahmad2 and J.S. Siddiqi3
1Departmentof Research, Dow University of Health Sciences, Karachi, Pakistan; 2Pharma Professional Services, Karachi, Pakistan; 3Department of Statistics, University of Karachi, Pakistan
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.
A Prospective Study on Adverse Drug Reactions in an Indian Hospital – Pages 149-162
Sivanandy Palanisamy, Kottur S.G. Arul Kumaran and Aiyalu Rajasekaran
Department of Pharmacy Practice, KMCH College of Pharmacy, Coimbatore-48, India
Abstract: Background:ADRs have a major impact on public health, reducing patients’ quality of life and imposing a considerable financial burden on the health care systems.
Objectives: The main objectives were to analyze the pattern and extent of occurrence of ADRs in the hospital, identify co-morbidities, past and present illness, assess causality and identify the offending drugs, assess the severity and preventability of adverse drug reactions.
Methods:Prospective, observational, spontaneous, reporting study with both active and passive methods.
Results:Thestudy was carried out from January 2009 to August 2012. A total of 950 ADRs were accepted from 1227 reported ADRs. Female patients experienced more number of ADRs when compared to male patients. Fever was the most commonly observed reason for admission. Maculopapular skin rashes were the commonly observed ADR in the study population. Amoxicillin and clavulenic acid combination implicated more number of ADRs in the antibiotic category than others. Sixty one percent of the ADRs were moderate in severity followed by minor and severe ADRs. Most of the reactions in this study population were managed by withdrawing the offending drug and rechallenge was performed in few subjects. Most of the ADRs were definitely preventable (40%) and were predictable in nature. Eighty percent of the reactions were probably related to offending drugs, 758 reactions were likely to cause ADRs. Twenty five percent ADRs were treated symptomatically in the study population.
Keywords: Adverse drug reactions, Pharmacovigilancce, Spontaneous reporting, Allergic reactions, Observational study.
Evaluation of Diuretic Activity of Isatin Derivatives in Wistar Rats – Pages 141-148
E. Venkateshwarlua,b, B.S. Sharvana Bhavab, K. Umasankarb and J. Venkateshwar Raoc
aDepartment of Biotechnology, Acharya Nagarjuna University, Guntur, 522510, India; bVaagdevi College of Pharmacy, Hanamkonda,Warangal, 506001 , India; cTallaPadmavathi College of Pharmacy, Orus, Warangal, 506002, India
Abstract: In the present studies we have synthesized ten derivatives of novel isatin-3-[N2-(2-benzalaminothiazol-4-yl)]hydrazone and characterized by the help of physical and spectral data. The selected male Wistar albino rats were divided into different groups: control, urea (1 g/kg), furosemide (5 mg/kg), of isatin derivatives (Ia-Ij, 10 and 100 mg/kg) treated groups. All the drugs were administered orally and animals were pretreated with normal saline (25 ml/kg) before start the experiment. The urine volume (in ml) and content of Na+, K+ & −Cl were measured in the urine of rats at 5th hour. The volume of urine output increased significantly (p<0.05) in urea, furosemide and also isatin derivatives treated groups when compared with control groups. The diuretic activity of isatin derivatives were exhibited moderated to less when compared with furosemide. The diuretic response with its electrolyte of the isatin derivatives was highly remarkable in comparison with control group. Based on the results the isatin derivatives show hypernatremic, hypercholermic and hyperkalemic diuretics as conventional diuretics (furosemide).
Keywords:Isatin hydrazones, diuretic activity, hypernatremic, hypercholermic and hyperkalemic
Quality Attributes of Therapeutic Tea from Indian Herbs Sweetened with Stevia (Stevia rebaudiana) – Pages 134-140
Akhilesh Verma and Alpana Singh
Department of Food Science and Technology, Jawaharlal Nehru Krishi Vishwa Vidyalaya, Jabalpur – 482 004, India
Abstract: Eating healthy food is vital for wellness and prevention of disease. Teas are aqueous extractions of crude herbs and one of the most commonly used delivery system for natural health products. Stevia (Stevia rebaudiana) is a sweet herb having sweetness 200 to 300 times more than sugar with zero calorific value. Therapeutically stevia is antibacterial, antifungal, anti inflammatory, antimicrobial, antiviral, antiyeast, prevents cavities, cardio tonic, diuretic, hypoglycemic, hypotensive tonic and vasodilator. Hence, sensorily acceptable therapeutic tea sweetened with stevia was formulated, optimized and assessed for various quality parameters. Therapeutic tea was optimized at 10.25% stevia leaves, 7.28% nutmeg, 32.06% arjuna bark, 5.55% licorice and 6.41% of each of ginger, cinnamon, black pepper, fennel, nagarmotha and cardamom. It is recommended that 2.34 g of tea formulation is appropriate to make 100 ml of tea infusion. Herbal tea formulations contained 8.22-9.32% protein, 18.66-18.70% ash, 42.0-45.28% carbohydrates, 72.07-82.25 mg P, 268.25-271.62 mg Ca, 80.30-83.87 mg Mg, 12.8-13.65 mg Fe, 1.82-2.60 mg Cu, 1.37-1.57 mg Zn, 3.28-3.76 mg Mn and 15.84-19.80 mg ascorbic acid per 100 g of tea mix. Bright, sparkling and clear infusion of brown colour with pleasant aroma and taste was obtained from optimized therapeutic tea formulation which would be an alternative medicine for different therapeutic purposes with minimal calories. Microbial quality of the product packed in aluminium foil bag was well up to 3 months storage at ambient temperature.
Keywords: Cinnamon (Cinnamomum zeylanicum), Ginger (Zingiber officinale), Black pepper (Piper nigrum), Nutmeg (Myristica fragrans), Licorice (Glycyrrhiza glabra), Nagarmotha (Cyperus scariosus), Cardamom (Elletaria cardamomum), Fennel (Foeniculum vulgare), Arjuna (Terminalia arjuna).
Single Dose of Dietary Supplement Nutrex Lipo-6 Black® Limits the Post Exercise Hypotension Induced by Aerobic Exercise in Young Adults- Pages 127-133
Leonardo Medeiros Magalhães1, Caio Victor Coutinho de Oliveira2,Maria da Conceição Rodrigues Gonçalves2, Alesandra Araújo de Souza1 and Alexandre Sérgio Silva1
1Department of Physical Education, Federal University of Paraíba, João Pessoa, Paraíba, Brazil; 2Department of Nutrition, Federal University of Paraíba, João Pessoa, Paraíba, Brazil
Abstract: Objective: to evaluate the blood pressure (BP) behavior and sympathetic activity in response to an aerobic exercise session after taking a dose of Nutrex Lipo-6 Black®.
Methods: This randomized, placebo-controlled study utilized seventeen subjects, divided in supplementation (n=10, 26.5±5.3 years) and placebo groups (n=7, 22.4±2.8 years). They ingested a dose of Nutrex Lipo-6 Black® (containing synephrine, caffeine, yohimbine and diiodine)or placebo and underwent a session of 40min of aerobic exercise of moderate intensity. Heart rate (HR), BP and cardiac autonomic balance (measured by heart rate variability) (CANA) were monitored at baseline, 30min after supplementation, at the end of the exercise and every 10min during a recovery period of 30min.
Results: After 30min of intake, Nutrex Lipo-6 Black® and placebo groups exhibited HR, BP and CANA similar to each other and in relation to the pre-supplementation moment. At the end of the exercise all variables showed a rise in relation to rest, but without statistical difference between groups (p>0,05). Moreover, at 30min of recovery, the Nutrex Lipo-6 Black® group presented with diastolic hypertensive response (increase of 4.2 mmHg) and a discrete post-exercise hypotension only to systolic pressure (-0.2 mmHg) relative to the pre-supplementation, while the placebo group showed evident both systolic and diastolic hypotension (-6.3 and -0.5 mmHg, respectively). HR and CANA were similar to pre-supplementation at this time.
Conclusion: single dose of Nutrex Lipo-6 Black® is able to limit the benefits of an exercise session in reducing BP, even without affecting the resting conditions of BP and CANA.
Keywords: Dietary Supplements, Sympathetic Nervous System, Exercise, Blood Pressure, Heart Rate, Post-Exercise Hypotension.
The Effects of Consumption L-Arabinose on Metabolic Syndrome in Humans- Pages 116-126
Ziming Yang1, Dianpeng Li1, Haiying Jiang1, Guiyun Qian2, Weiguo Sui3, Guimian Zou3 and Hourui Zhang1
1Guangxi Key Laboratory of Functional Phytochemicals Research and Utilization, Guangxi Institute of Botany, Chinese Academy of Sciences. No. 85 Yanshan Road, Yanshan District, Guilin, 541006, China; 2The Second People’s Hospital of Guangxi Zhuang Autonomous Rcglon. No. 1 Xinqioayuan Road, Guilin, 541006, China; 3181st Hospital of Chinese People’s Liberation Army, No. 46 Chongxin Road, Guilin, 541006, China
Abstract: On the basis of results in rat, L-arabinose decreased total cholesterol (TC), triglycerides (TG), fasting glucose, systolic blood pressure, increased high-density lipoprotein cholesterol (HDLC), and enhanced the glucose tolerance. The primary purposes of the present study was to determine the effects of consumption L-arabinose on metabolic syndrome in humans.All volunteers received L-Arabinose by dissolving it in water. The volunteers didn’t change the diet habits and lifestyles during the whole experiment. The trial lasted for 6 months, and experimental indicators were assayed every two months, which including weight, waist circumference, blood pressure, TG, TC, HDLC, low-density lipoprotein cholesterol (LDLC), fasting plasma glucose, erum uric acid, serum creatinine (Scr), bloodurea nitrogen (BUN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Our results showed that the L-arabinose decreased waist circumference, TC, fasting glucose, serum uric acid, ALT and slightly increased HDLCand slightly decreased diastolic blood pressure after 6 months. A tendency for decreased waist circumference, TC, fasting glucose, serum uric acid, ALT after 2, 4 and 6 months of treatment with L-arabinose was observed. In addition, L-arabinose decreased TC, LDLC and body weight. No effects on Scr, BUN, AST. In conclusions, L-arabinosewould reduce most the metabolic syndrome risk factors(decreased circumference, TC, fasting glucose, and so on), and treat the metabolic syndrome as a whole.The present study would provides strong evidence that long-term received L-arabinose would be manage metabolic syndrome.
Keywords: L-arabinose, metabolic syndrome, triglycerides,ALT, waist circumference.
Antagonistic Effect of the Lactic Bacteria Isolated from the Camel Milk on Staphylococcus aureus in Yoghourt Manufacturing – Pages 108-115
Belkis Abdessemed1 and Arezki Bitam1,2
1Département de Biologie, Université de Blida, Algérie; 2Département de Nutrition Humaine, Ecole Nationale Supérieure Agronomique, El-Harrach, Algérie
Abstract: This paper deals with the lactic bacteria found in the raw camel milk producing antibacterial substances. Samples of milk were obtained from female camels of herds from nomads living in the south of Algeria. The antibacterial activity of the bacteria was tested on Staphylococcus aureus strains and to highlight this activity in a yoghourt for therapeutic purpose.
Among the seven (07) strains of lactic bacteria which were isolated from camel milk Lb. fermentum (Lc17) presented the highest antagonistic effect on S. aureus. After incorporation in the yoghourt ,It was verified that there was no interaction between the lactic ferments of yoghourt and Lb. fermentum and no modification of the acidity. However the realization of a yoghourt containing Lb. fermentum with shown a total inhibition of Staphylococcus aureus to a load 5,87 log UFC compared to that of yoghourt made up exclusively of lactic leavens, after 4 hours of incubation in mixed culture.
Keywords: Antagonism, lactic bacteria, Therapeutic purpose, camel, Staphylococcus aureus, yoghourt.