Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 3, Issue 2, 2016

Worldwide, every year is described 9 million of new cases of pulmonary tuberculosis (PTB) and this disease is responsible for 1.5 million deaths. The main causative agent of PTB is Mycobacterium tuberculosis (MTB). The bacillus has a cell wall rich in lipids and shows very slow growth, which raises difficulties to the execution of cultivation methods. Although the cases and deaths are still high, progress is being made aiming to Read More

Background: Regulation of drugs across the world has been a crucial component in providing quality products around the globe. Henceforth different drug administrative powers are moving forward for initiating better regulatory framework which will lead to easier differentiation of superior medicinal products to that of sub-standard ones. For this purpose legitimate dossier preparation becomes essential so that a w Read More

Background: Older patients with diabetes require a provider to consider health status and the ability to self-manage with concomitant morbidities. Careful insight into pharmacotherapy regimens that offer the best profile with appropriate efficacy is critical. Diabetes is a common disorder that is often undertreated in the elderly because of the concern for hypoglycemia. A review of the literature and if newer basal insulin formulat Read More

Background: In this era of evolution, quality and safety of pharmaceutical dosage forms have been given a prime importance. In this context, a detailed knowledge about physical and chemical properties of excipients is not sufficient, but information about safety and regulatory status of these materials is now essential to know. The present work will be beneficial to focus more on the safety, quality and stability of pharma Read More

Background: In many African countries, cultural practices along with deteriorating economic conditions have resulted increases in the number of cases of domestic violence. Furthermore, high levels of gender equality has contributed to a normative climate of acceptance and justification of domestic violence. The primary purpose of this study is to examine the relationship between women’s autonomy and justification for do Read More

Background: Drug eluting stents (DES) are the most frequently used devices during coronary interventions. Bioresorbable vascular scaffold (BVS) were developed to circumvent some of the limitations of DES. Worldwide, there is very limited experience with this device. The aim of our study was to see the initial challenges encountered by a single center while using this new device. Methods: We implanted a total of 24 BVS in Read More

Background: Negative bionmial regression is a common statistical model for analyzing count data. For example, hypoglycemic events occurred in clinical trials studying anti-diabetes therapies are often analyzed using negative binomial regression. Recently, methods have been developed for calculating statistical power and sample size needed for negative binomial regression with a common shape parameter across treatmen Read More

Background: Joint hypermobility syndrome (JHS) is one of the most common heritable genetic disorders of connective tissue, characterised by excessive joint range of motion and the presence of musculoskeletal symptoms. Prevalence estimates of JHS range from 5% to 18% and vary with gender, age and ethnicity. JHS is associated with generalised joint laxity, joint instability, motion incoordination, decreased joint position s Read More

Background: In situ gel is a type of floating polymeric formulation that is in solution form before administration, but undergoes gelation in situ to form a gel upon contact with physiological fluids. Objective: The objective of present study was to design and evaluate sustained release in situ gel suspension of Glimepiride (GLP) and compare it with marketed formulation. Method: Different formulations of GLP were prepared using Read More

The present investigation aims at development of spray-dried microspheres for formulation of roxithromycin dispersible tablets. The spray drying process was optimized using a central composite design to study the effect of two critical variables - amount of polymer Eudargit EPO® (X1) and inlet temperature (X2) on entrapment efficiency of drug and percentage cumulative drug release (% CDR). The maximum entrapment e Read More