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- Volume 3, Issue 3, 2016
Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 3, Issue 3, 2016
Volume 3, Issue 3, 2016
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Regulatory Aspects of Post-Approval Safety Reporting for Generic Drug Products in the US
Authors: Priti J. Mehta and Chandni K. DoshiBackground: Generic drugs are those that are identical or bioequivalent to a brand name drug or innovator drug in active ingredient(s), dosage form, strength, route of administration, intended use, quality, safety and performance characteristics. Pharmaceutical companies need to submit Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for approval to market a generic product in the Read More
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Medical and Dental Implications of Down Syndrome: A Review Part 1: General and Craniofacial Characteristic
Authors: Batool Ghaith, Mawlood B. Kowash and Manal El-HalabiDown syndrome (DS) is a genetic disorder characterized by the presence of three chromosomes instead of two, specifically chromosome No. 21. The special needs status of DS individuals makes them more prone to several medical conditions such as congenital heart disease, gastrointestinal tract anomalies, immunodeficiency, visual impairment, skeletal defects, audiological dysfunction, seizures, acute leukaemia and thyroid Read More
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Pharmacokinetics-Guided Dosing of 5-Fluorouracil for Precision Cancer Treatment: A Focus on Colorectal Carcinoma
Authors: Yanming Chen and Nelson S. Yee5-Fluorouracil (5-FU) is a principal chemotherapeutic agent for treatment of a variety of malignant diseases. The standard method for dosing of 5-FU has been based on body surface area. Significant variation of plasma levels of 5-FU among individuals has been shown to influence the clinical outcomes. Accumulating data suggest that area under the concentration versus time curve (AUC)-based dosing of 5-FU improves the cli Read More
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Development of a Registry for Down Syndrome in the Gulf Area of the Middle East
More LessSystems for organizing specific data about large groups of people have been in existence for many years; their structures depend greatly on their purposes and goals. This paper describes the creation of a registry and database detailing demographics and co-occurring conditions of a population with Down syndrome living in the United Arab Emirates. The Gulf Down Syndrome Registry-Abu Dhabi seeks to describe the p Read More
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Assessment of Knowledge and Attitude Towards Hepatitis C Infection Among Medical and Health Science Students in Ras Al Khaimah, United Arab Emirates
Introduction: Hepatitis C virus (HCV) commonly causes chronic liver disease. The majority of the countries in the Middle East have intermediate or high endemicity of HCV. Adequate knowledge, attitude and behavior, are critical to decline the spread of this infection. In this study, we aim to assess the level of knowledge and attitude of medical and health science students in Ras Al Khaimah (RAK), United Arab Emirates (UAE), Read More
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An Educational Altered Eating Intervention’s Effect on Chronic Pain, Satisfaction, and Routine
Authors: Chelsea E. Mummert, Kathleen E. Yancosek and Brandon J. GoffChronic pain is prevalent and significantly disrupts functioning. One current theory suggests that chronic pain is influenced by systemic inflammation. Altered eating (AE) has been shown to improve chronic pain by reducing inflammation; however it is necessary to consider practicality and compliance in a real world setting. Objectives: Evaluate the response and practicality of an educational AE program on p Read More
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A Pilot Study on Wet Age Related Macular Degeneration in Chennai and Some Parts of Kerala
Authors: Santhi Vinodh, Ramchand N. Chaniyilparampu and Reena AroraBackground: Age related Macular Degeneration (AMD) is one of the leading causes of blindness that leads to an irreversible loss of vision among elderly population. The prevalence of AMD in India is likely to increase due to high population growth and increased life expectancy of the individuals. The epidemiology of AMD in India is similar to those found in developed countries. Materials and Methods: A pilot study base Read More
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Features and Factors Associated with Drinking Problems or Illegal Drugs Use: A Cross Sectional Cohort Study with Patients of a Psychosocial Care Service
Authors: Giuliano Di Pietro, Ravena Melo Ribeiro da Silva, Jessyca Costa Santos, Tenisson Santos Santana, Breno A. de Menezes Rezende, Ana Paula de Araujo Santana, Maraiza Alves de Oliveira, Camila Batista dos Santos, Jussara Secundo dos Santos, Adriane Almeida Souza, Jamille C. da Silva Santos, Riviane da Costa Ribeiro Silva, Lynn Karol Leal Santos, Noilson Junior Passos Souza, Felipe Rosa dos Santos Lima, Izabelle C. Figueiredo Souza, Cibele Ferreira Cezar, Jose Cicero de Alcantara, Raphaella Gois Barros, Daniela Souza da Silva, Jussara Menezes Freire, Silvia Costa Santos and Claudio Moreira LimaBackground: Abusive alcohol consumption is a public healthcare problem all across the world, carrying a heavy toll of almost 6% of all deaths. Nearly 5% of the world population makes use of illicit drugs frequently. The treatment for patients with any substance abuse disorder, whether it is alcohol or another drug, requires specialized view. The purpose of this research was to characterize a group of users at a Psychosocial C Read More
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A Rapid LC-ESI-MS/MS Method for the Quantitation of Salicylic Acid, an Active Metabolite of Acetylsalicylic Acid: Application to in vivo Pharmacokinetic and Bioequivalence Study in Indian Healthy Male Volunteers
Authors: Dhiman Halder, Shubhasis Dan, Easha Biswas, Pradipta Sarkar, Umesh C. Halder and Tapan K. Pal
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