Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 7, Issue 1, 2020

Periodic safety update report (PSUR) is now known as the Periodic Benefit-Risk Evaluation Report (PBRER). In July 2012, as per the new European Legislation, 16 Good Pharmacovigilance Practices (GVP) modules came into effect by replacing Vol 9A guidelines. GVP module VII provides the guidance for the preparation, submission and assessment of PSURs. There are twice as many sections to the new PSUR as compared to Read More

Background: Biological products are the chemicals in the form of medicines that are prepared from the living cells through highly intricate manufacturing techniques that should be handled and managed under favorable conditions. The regulation of the biosimilar products consists of significant challenges, since they are part of the growing sector of the pharmaceutical industry and normally used by human beings. Th Read More

Haemovigilance is an organized and effective process of monitoring, identifying, reporting, investigating and analyzing adverse events and reactions in case of blood transfusion and during the manufacturing process of blood products. This system ensures the quality and safety aspects of blood transfusion, that bring out corrective and preventing actions and advancement in the transfusion system. Nowadays, most of th Read More

Background: Literature review suggested that regulatory guidelines should be harmonized for better processing of applications and for the upliftment of the regulatory field. Therefore it was thought worthwhile to compare the guidelines for countries where there is requirement of harmonization. Kosovo, Ukraine and Serbia were selected because of being European countries and still they are not a part of EU. Introd Read More

Background: Eperisone hydrochloride possesses short biological half-life due to first pass metabolism resulting in low bioavailability and short duration of response with toxic effects, ultimately limits its utilization for treatment of muscle spasm. Objective: In view of this background, current study was designed for the development of Eperisone hydrochloride-loaded microemulsion and Eperisone hydrochloride-loaded microe Read More

Introduction: A randomized clinical trial is known as the best and most effective way to assess the effects of interventions if it is properly planned and implemented. The purpose of this study was to evaluate the quality of clinical trials published in Persian internal journals by Iranian researchers. Methods: In this cross-sectional study, all the clinical trials published by Iranian researchers in the Iranian Journals in 2014, Read More

Background: A DMF consists of confidential information, usually related to Chemistry, Manufacturing and Control (CMC) of the drug substance. DMF is prepared and submitted by the pharmaceutical manufacturer solely to the regulatory authority of the respected country where he wants to market. Objective: Compare the regulations of the emerging markets with that of a regulated market and to highlight the stringent requi Read More