Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 1, Issue 2, 2014

Obstructive Sleep Apnoea / Hypopnoea Syndrome (OSAHS) is associated with obstruction of the upper airway and occurs as a result of repeated closure of the upper airway during sleep, either by anatomical or patho-physiological factors. During these episodes, the diaphragm and chest muscles involved in breathing work actively to re-open the occluded airway and suck air into the lungs. The aim of this study is to clinical Read More

A global world, with global diseases requires a global clinical research approach towards the achievement of Global Health as a principal goal. This requires collaboration among stakeholders, including inter-sponsor and intercenter/ investigator co-operation at an international level. However, this international collaboration may be challenged due to significant barriers resulting from different cultures, regulatory environment a Read More

This review article discusses the current challenges and future trends on research and development (R&D) activities. Development of a new medicine becomes more complicated, challenging and expensive as well as more risky because of further obstacles during the registration. Clinical Research phases of R&D consume more than two thirds of the development cost. So sponsors will be veered towards business operation Read More

Experiment on human for the purpose of finding new treatment of the emerging ailments is a continuous process. The regulatory bodies regulate all activities related to human experimentation. Due to increase in research activities now-a-days, it is not always possible to maintain the equal focus for all the activities through the central regulatory agency. In order to maintain the stringency, regional Institutional Ethics Commit Read More

Bioavailability and bioequivalence studies play a major role in the drug development phase for both new formulations and their generic equivalents. There are various investigations to assess bioequivalence and each regulatory authority has its own guidance for the conduction of bioavailability and bioequivalence studies before approval of generic products. Bioequivalence studies are the primary needs for generic products to e Read More

The objective of this paper is to provide insight and better understanding of the regulations for the scored tablet in regulated markets and World Health Organization. Splitting of tablets is done for various reasons; but is associated with certain problems such as inaccurate split resulting in change of dose, enhanced drug degradation due to atmospheric exposure, change in dissolution rate and extent. The accuracy of split i Read More

Early Childhood Caries (ECC) is a chronic, transmissible infectious disease affecting the primary teeth. The etiology of the condition is a combination of factors including frequent consumption of fermentable carbohydrates as liquids, especially when the baby is sleeping, with on-demand breast- or bottle-feeding. Other factors include oral colonization by cariogenic bacteria (especially mutans streptococci), poor oral hygiene and po Read More

An incidence of overall oral sequelae in leukemic children of 54% has been reported in the literature. Oral complications include mucositis, fungal and viral infections, salivary gland hypofunction, dental caries, and others. Mucositis accounts for the most common complication followed by fungal infections and viral infections. It has also been reported that the quality of life of these children is affected. Dental healthcare prof Read More