Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 5, Issue 1, 2018

In the ASEAN countries, accessibility of generic medication is a vital issue and regulatory requirements vary from others. Hence, it is a challenging task for the pharmaceutical companies to develop a single document which can be concurrently submitted in various countries for approval. There are 10 ASEAN countries with different regulatory authority for the approval process of a drug. Though all the countries are harmonized, Read More

Background: Many biomedical researchers and stakeholders may be unfamiliar with clinical trial concepts, designs, and factors affecting data integrity. Complexities are further increased in multinational trials. This article is intended to summarize the clinical trial process, with emphasis on the planning and design of multinational trials. The goal is to provide insight and guidance to the international research community. Clini Read More

Immunoglobulins (IgG) derived from the human plasma are used as biotherapeutics primarily in the form of polyclonal IgG or as hyperimmune sera. Intravenous Immunoglobulin (IVIG) has been the driving force of the growth of plasma products industry. In India, the demand for IVIG has been growing on account of increased usage of IVIG in the treatment of primary immunodeficiency as well as for newer neurological ind Read More

Background: In the present investigation, a self-emulsifying drug delivery system (SEDDS) has been formulated for enhancing dissolution rate, solubility and bioavailability of drug rosuvastatin belonging to class II of Biopharmaceutical Classification System (BCS). Methods: Saturation phase solubility studies were performed for selection of a suitable oil, surfactant and co-surfactant. Pseudo ternary phase diagrams were draw Read More

Background: Good Clinical Practice (GCP) and the US Food and Drug Administration (FDA) regulations require auditing and monitoring of clinical trials to assure regulations, policies and the protocol are being followed. This improves the quality and reliability of a study. Objective: Virginia Commonwealth University (VCU) has implemented an auditing and monitoring tracking and reporting system within OnCore® a Clinical Read More