135 research outputs found

    CLINICAL DATA MANAGEMENT IMPORTANCE IN CLINICAL RESEARCH

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    ABSTRACTOver the last few decades, most of the pharmaceutical companies and research sponsors are facing a lot of challenges in clinical research for theirnew drug approval. The sponsor research needs a high-quality data report for getting new drug approval from Food and Drug Administration for theirmedical products. Clinical trial data are important for the drug and medical device development processing pharmaceutical companies to examineand evaluate the efficacy and safety of the new medical product in human volunteers. The results of the clinical trial studies generate the mostvaluable data and in recent years; there has been massive development in the field of clinical trials. A good clinical data management system reducesthe duration of the study and cost of drug development. Further a well-designed case report form (CRF) assists data collection and make facilitatesdata management and statistical analysis. Nowadays, the electronic data capture (EDC) is very beneficial in data collection. EDC helps to speed up theclinical trial process and reduces the duration, errors and make the work easy in the data management system. This article highlights the importanceof data management processes involved in the clinical trial and provides an overview of the clinical trial data management tools. The study concludedthat data management tools play a key role in the clinical trial and well-designed CRFs reduces the errors and save the time of the clinical trials andfacilitates the drug discovery and development.Keywords: Pharmaceutical, Clinical trial, Clinical data management, Data capture

    The effects of changes in glutathione levels through exogenous agents on intracellular cysteine content and protein adduct formation in chronic alcohol-treated VL17A cells

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    Alcohol-mediated liver injury is associated with changes in the level of the major cellular antioxidant glutathione (GSH). It is interesting to investigate if the changes in intracellular GSH level through exogenous agents affect the intracellular cysteine content and the protein adduct formation indicative of oxidative insult in chronic alcohol treated liver cells. In VL-17A cells treated with 2mM N-acetyl cysteine (NAC) or 0.1mM ursodeoxycholic acid (UDCA) plus 100mM ethanol, an increase in cysteine concentration which was accompanied by decreases in hydroxynonenal (HNE) and glutathionylated protein adducts were observed. Pretreatment of 100mM ethanol treated VL-17A cells with 0.4mM buthionine sulfoximine (BSO) or 1mM diethyl maleate (DEM) had opposite effects. Thus, altered GSH level through exogenous agents may either potentiate or ameliorate chronic alcohol-mediated protein adduct formation and change the cysteine level in chronic alcohol treated VL-17A cells. The gene expression of non-treated and ethanol-treated hepatocytes in 2 microarray datasets was also compared to locate differentially expressed genes involved in cysteine metabolism. The study demonstrates that increased protein adducts formation and changes in cysteine concentration occur under chronic alcohol condition in liver cells which may increase alcohol-mediated oxidative injury

    Comparative molecular docking analysis of essential oil constituents as elastase inhibitors

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    Elastase is a protease or proteolytic enzyme, responsible for the breakdown of protein. There are eight human genes encoding for elastase, of which Elastase-1 (CELA-1) and Elastase-2 (ELANE) has significant implications on human diseases. Elastase-1 is primarily expressed in skin keratinocytes and is regarded as the major cause for the blistering in bullous pemphigoid, which affects the skin. On the other hand, Elastase-2 (ELANE), is expressed in the azurophil granules of neutrophils, is responsible for pulmonary emphysema and cyclic hematopoiesis a rare genetic disorder. Elastase is also produced by bacteria such as Pseudomonas aeruginosa, and forms the virulent factor in human. The ingredients from essential natural oils were found to have wound healing effects on non-healing wounds that is interfered by elastase due to microbial infection. Essential oils such as citral, citronellal, geranial, geraniol, and thymol were screened for their inhibitory activity on elastase produced by neutrophil, skin, and Pseudomonas aeruginosa by docking and were analyzed for their subcutaneous ADMET properties by ADME – TOX – Web server

    INTENTION TO USE FINGERPRINT SYSTEM IN ELECTRONICS INDUSTRY

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    Purpose: The aim of this study is to assist the Malaysian electronics companies in reducing the non-value added practices and in return, will minimize the cost and improves productivity with the use of the fingerprint system. Methodology: This study uses a quantitative research approach and data were sampled from 137 front-line employees using simple random sampling technique. Result: The empirical findings of the study confirm that perceived usefulness and perceived ease of use significantly affect the intention to use the fingerprint system. However, there was not enough evidence that relative advantage has any effect on the intention to use the system.  Implications: The study results affirmed that business organizations, especially electronic companies should transform their use of conventional attendance system to fingerprint system in improving efficiencies and effectiveness within the human resource practices
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