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, still every country differs in some local requirements such as administrative, quality, clinical and non-clinical documents. In the present scenario, countries like Cambodia, Laos, Vietnam and Myanmar are looking for importation of generic drugs. The purpose of this study was to provide a comparative overview on generic drug product regulation and to facilitate proper knowledge regarding critical issues, differences and similarities of drug regulation in ASEAN countries. There is a similar outline for all counties but varies from their regulatory aspects such as the need of letter of authorization, site master file, patient information leaflet, bioequivalence and clinical requirement. The present paper focuses on the specific regulatory process of Myanmar as it exhibits the high import rate as compared to other countries and it has some countryspecific guideline for market authorization.

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. Clinical trial guidelines have been generated by reviewing textbooks, published articles, regulatory guidelines, and the authors' personal experience. The workflow reported here summarizes the literature to produce a practical template in order to guide the planning and design of multinational clinical trials. This template can be broadly useful during the planning and design steps of a nascent clinical trial. However, in-depth knowledge of each individual process of a clinical trial is essential. One is encouraged to use this template as a guide for early drafts of a clinical trial. Conclusion: Detailed research for the template components can further enhance the knowledge of biomedical research structures, improve the quality of clinical trials, and ultimately enhance the published results.

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 indications. In order to assure patient safety, Government of India has devised and implemented regulations for import, manufacturing and marketing of these products. Regulatory provisions in India have basic common features such as review of data in marketing authorization application, inspection and licensing of manufacturing facilities, process and quality systems, control agency batch review and release of approved products. Nevertheless, there remains a room for considering additional safety requirements for the enhanced confidence in the safety of this plasma-derived product as well as research strategies for its judicious use that may provide additional options to address patient needs. This article gives an overview of the current quality assurance measures of plasma-derived IVIG in India and further strategies to improve its quality as well as judicious use.

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 drawn for selecting ratio of oil, surfactant and co-surfactant required for formation of microemulsion. Results: The optimized rosuvastatin SEDDS formulation contained 46.66% Tween 80, 30% Oleic acid and 23.34% PEG 400 as surfactant, oil and co-surfactant respectively with smallest globule size of 337 nm. The percent transmittance of formulation F-8 was found to be 88.70%. Conclusion: SEDDS formulation F8 showed a much high drug release (87.25%) in comparison to marketed formulation (42.95%).

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 Trial Management System. Having an institutional process for collecting and tracking study specific findings allows for reporting on a particular study but also allows for trends in deficiencies to be recognized within investigative teams and the institution. Looking at these deficiencies then allows for education across the university. This article will highlight the steps used to develop the checklists and results of the first 18 months of utilization. Conclusion: Expansion and creation of a VCU specific checklist have allowed for standardization, tracking, reporting and education around compliance with regulations, policies, and best practices.