Publications by authors named "Ohoud A Almadani"
Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challenging for regulatory authorities to conduct on-site inspections. Smart GxP inspections are an oversight approach developed by the SFDA to enable remote compliance assessments of establishments. In this type of inspection, appropriate technical methods and tools (such as livestreaming video) are used without requiring the presence of inspectors onsite, ensuring efficient utilization of resources and the efficiency of inspection process.
View Article and Find Full Text PDFBackground: This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017.
Methods: This was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the impact of the coefficient of variation of within-subject variability (CVw) on some design aspects, and providing an in-depth assessment of bioequivalence trial submissions that were deemed insufficient in demonstrating bioequivalence.
Article Synopsis
- - The study explored the link between drug prices and drug shortages in Saudi Arabia from 2017 to 2020, analyzing data provided to the Saudi Food and Drug Authority (SFDA).
- - Researchers categorized drugs based on their foreign-to-Saudi price ratio (FTSPR) and used a negative binomial regression model to assess how drug prices related to shortage incidents.
- - Results showed that drugs with higher foreign prices (Group 1) had more shortage incidents compared to those with lower foreign prices (Group 3), suggesting higher international prices might lead to more shortages.
Article Synopsis
- VAERS is a U.S. system created to track adverse events following immunizations to ensure vaccine safety, gaining increased attention during the COVID-19 pandemic.
- An observational study analyzed VAERS data from 1990 to 2021, focusing on the patterns of adverse events and comparisons of incidents across different years and vaccines.
- The study found a significant rise in reports during 2021, with COVID-19 vaccines (Moderna, Pfizer-Biontech, Janssen) being the most reported, while common symptoms included headache, pyrexia, and fatigue.