Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 3, Issue 3, 2016

Background: 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 US. After a drug product is marketed, it is mandatory for pharma companies to report adverse events occurring due to their drug products to the FDA and this is done by the Pharmacovigilance department. The objective of this article is to provide an understanding of the pharmacovigilance department and the activities conducted by them to report adverse events to the FDA and the challenges faced by them while carrying out these activities. Conclusion: The reporting of adverse events constitutes an important function of the pharmacovigilance department as it contributes to identification of certain adverse events which were previously unknown. Identification of any new adverse drug event may necessitate further regulatory actions by FDA such as label changes, market withdrawal depending on its severity. Non-compliance to postapproval safety reporting may result in suspension of marketing approval of the drug product by the FDA.

Down 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 disorders. A thorough knowledge of the unusual medical and orofacial abnormalities and their implications is crucial for a successful dental preventive and treatment planning. This paper provides an updated review of DS definition, etiology, epidemiology, medical problems and dentofacial abnormalities.

5-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 clinical efficacy and safety profile. In this article, we reviewed the pharmacokinetics (PK) of 5-FU and discussed the studies of PK-guided dose adjustment of 5-FU in colorectal cancer. In recent studies, the value of PK monitoring and modifying of 5-FU plasma level based on AUC has been investigated. As demonstrated by these data, AUC-based dosing is associated with improved treatment responses and reduced toxicity. Commercially available immunoassay is available to accomplish PK-based dosing of 5-FU, and that is increasingly utilized in routine clinical practice. In conclusion, monitoring of plasma levels of 5-FU is a promising method to improve the outcome of patients with colorectal cancer in terms of clinical efficacy and toxicity. Large randomized trials are warranted to further verify this hypothesis and generalize the use of PK-guided dosing of 5-FU for precision cancer treatment.

Systems 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 population’s demographics and associated co-occurring conditions, bringing attention to their unique needs through description of findings.

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), towards HCV infection. Materials and Methods: A cross sectional survey was conducted from March – May 2014 among the students of medical, dental, nursing and pharmacy colleges of RAK Medical and Health Science University (RAKMHSU) using a structured, pre-validated questionnaire with 26 close-ended trichomotous questions. They were divided into 2 groups for statistical analysis. Group 1 consisted of medical students and group 2 consisted of pharmacy, nursing and dental students put together. Results: Total 409 students (171 medical and 238 paramedical) participated in the study. The mean knowledge levels were partial toward HCV infection in our survey with better knowledge in medical students compared to paramedical students. The majority of the correct answers were related to the nature and transmission of the viruses. The knowledge regarding prevention and treatment was poor in paramedical students. Overall attitude towards infected individuals were average in group-1 but poor in group-2. The awareness is poorer in whether an infected professional should be involved in patient care and having the skills needed to treat patients with HCV. We found a positive correlation between students’ knowledge and attitude. Generally, awareness steadily increased with each year of study. Conclusion: Awareness of students in our region is partial to weak, especially on prevention and in those groups of students who have less close contact with patients. There is an urgent need for improvement of awareness of HCV.

Chronic 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 perceived pain, quality of life, and routine for adults with chronic pain. Methodology: Using single-subject research, an educational AE intervention with three data collection phases was implemented to explore effects on pain, quality of life, and routine. Results: Data showed a trend toward reduced pain levels. AE varied based on routine and quality of life remained relatively stable over time. Increased self-efficacy corresponded with more days of self -selected AE. Conclusion: AE in real world settings may be beneficial as a self-management approach for chronic pain management in self-efficacious individuals.

Background: 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 based on a clinical survey was conducted, in which 77 ophthalmologists were interviewed in Chennai and some parts of Kerala using a structured questionnaire. The parameters studied were number of AMD patients seen by the doctor, age and genderbased distribution, risk factors like smoking and family history, and treatment methods. Preliminary statistical calculation was done to interpret the information obtained from the survey. Results: The incidence of dry AMD is more than wet AMD in our study area. AMD was observed to be higher in population aged 60 years and above. Age and smoking were found to be the main risk factors for AMD. Lucentis and Avastin were the most commonly used anti-VEGFs for the treatment of wet AMD. The efficacy of Lucentis was found to be better than Avastin and Macugen. Conclusion: Our data reveals the current trend (2015-2016) of incidence, determinants and treatments of AMD in a small part of South Indian population. This information would be helpful in designing further full scale studies to determine the actual magnitude of the disease.

Background: 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 Care Center for Alcohol and other Drugs, drawing a social demographic profile, consumption habits, assessing the connection of addiction history in the family and the problems resulting from the use. Methods: Three hundred patients are registered and attending the institution regularly in the Psychosocial Care Center for Alcohol and other Drugs, For statistical dates 276 patients completed all the steps of the research and these were used for the statistic demonstration. The study was conducted in a small town in the countryside of Brazil’s northeast were included in a cross sectional cohort study in which several social and demographic variables were analyzed: gender, age, ethnicity, educational background, occupational status, and others, regarding consumption habits and problems resulting from the use. The analysis was carried out using the Statistical Package for the Social Sciences SPSS 20.0, and significance (p ≤0.05) based on Pearson’s correlation test. Results: 94.6% of the individuals analyzed were male, 20% of them reportedly white and at an average age of 36, having started using drugs at the age of 18 or less. Alcohol and cannabis were the ones used at the earliest stages. Data showed multiple chemical dependency in 65.2% of patients, predominantly alcohol, cannabis, tobacco, cocaine and crack, of those, almost 85% were alcohol dependent. The study showed a reverse correlation owing to the fact that the variety of drugs used tend to decrease as individuals get older. Family relationships and work performance were shown to be the most affected by drug abuse. Conclusion: The individuals who seek help at the Psychosocial Care Center for Alcohol and other Drugs are almost exclusively male, employed, with an average 14-year-long history of substance abuse. Although multiple chemical dependencies are a relevant aspect, alcohol remains the predominant drug among users.