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INTEGRATION OF ARTIFICIAL INTELLIGENCE AND PREDICTIVE ANALYTICS IN POST-MARKETING SURVEILLANCE SYSTEMS
Get PDFThe continuous monitoring of pharmaceutical products and medical devices following regulatory approval represents fundamental pillar of public health protection, functioning as the principal safeguard for identifying and mitigating medication-related risks in real-world clinical settings. This comprehensive analysis investigates the contemporary landscape of post-approval safety monitoring frameworks, examining both established regulatory structures and the revolutionary impact of artificial intelligence on drug safety surveillance activities. This review digs into how different countries handle post-marketing surveillance and adverse event reporting—examining approaches from major regulators like the FDA in the US, Europe's EMA, Japan's PMDA, and other important agencies worldwide. What emerges is a mixed picture: while there's some common ground in safety monitoring practices, each region has its own unique spin on implementation. Our analysis reveals that AI technologies can significantly boost traditional PMS methods, excelling at automating signal detection, finding patterns in complex data, and catching adverse events as they happen. We're also seeing predictive analytics mature to the point where it can flag potential safety issues well before they escalate into public health crises. Looking ahead, this review charts the path forward for AI-enhanced PMS systems, examining the regulatory hurdles that need clearing, the practical challenges of getting these systems up and running, and the opportunities for creating safety monitoring that anticipates problems rather than just responding to them. Ultimately, it's about building robust systems that make a real difference in keeping patients
FILFIL SIYAH (PIPER NIGRUM L.): AN INCREDIBLE MEDICINAL SPICE IN UNANI SYSTEM OF MEDICINE
Get PDFBlack pepper (Piper nigrum L.), commonly referred to as Filfil Siyah in Unani medicine, is one of the most widely consumed spices worldwide. Beyond its culinary importance, it has been traditionally employed in several systems of medicine, including those practiced in India and China, for a wide range of ailments. Therapeutically, it has been used for the management of conditions such as fever, indigestion, flatulence, toothache, common cold, cough, asthma, and hemorrhoids. The present review aims to systematically compile and discuss the available information on Piper nigrum L., covering its introduction, geographical distribution, macro- and microscopic characteristics, temperament (Mizaj), phytochemical composition, therapeutic actions, toxicity profile, corrective agents (Musleh), formulations in which it is used, and evidence from modern pharmacological investigations. Filfil Siyah (Piper nigrum L.) exhibits a broad spectrum of pharmacological activities, including anti-inflammatory, antioxidant, anticancer, neuroprotective, antimicrobial, and antidepressant effects. Its major bioactive alkaloids comprise piperine, chavicine, piperidine, and piperetine. The present review consolidates traditional knowledge and recent scientific findings on Piper nigrum, with a focus on its phytochemistry and therapeutic potential. This compilation is expected to serve as a valuable reference for future investigations aimed at isolating active constituents and exploring their pharmacological mechanisms
USFDA BIOLOGICAL EVALUATION AND SAFETY ASSESSMENT OF MEDICAL DEVICES
Get PDFIn this paper, I will give an extensive account of the regulatory process governing the food and Drug administration (FDA) of United States; dealing with the safety, efficacy, and quality control of the medical devices. It draws the reader’s attention to the history of the regulation of using medical devices with references to such legislations as Medical Device Amendments of 1976 and the FDA Safety and Innovation Act of 2012. The division of the devices according to the level of risks into Classes I, II, and III is mentioned, and the biocompatibility and safety testing with detailed description as provided in ISO 10993 portrays. The similarity between ISO 14971 corresponded to risk management procedures and ISO 13485 and cGMP to quality management systems in order to demonstrate regulatory stringency. Post-market surveillance processes are also discussed such as the MAUDE database and the 510 (k) / 522 pathways. In general, this paper supports the necessity of effective and changing regulation system to find the balance between medical innovations and the safety of population
Key Gingival Dimensions and Shapes of Maxillary Lateral Incisors in a Middle East Population – A Preliminary Report
Get PDFBackground: Numerous studies have demonstrated that the shape, size, angulation, and position of the maxillary lateral incisor significantly influence smile esthetics. The relationship of the lateral incisor to adjacent teeth—particularly the central incisor and canine—often described by the "Golden Proportion," also affects the perception of smile harmony. The purpose of this study was to evaluate whether a correlation exists between maxillary lateral incisor crown shapes and various periodontal parameters, including gingival and interdental characteristics.Materials and Methods: Clinical measurements were collected from 60 systemically healthy male and female individuals aged 21–35 years. Parameters recorded for each participant included crown width (CW), crown length (CL), height of the interproximal papilla (Ph), gingival angle (GA), mesiodistal width (MDW), and contact surface length (CS) of the maxillary lateral incisors. Based on the CW/CL ratio, participants were categorized into three crown shape groups: tapered, square, or ovoid. These groups were compared for statistically significant differences in clinical parameters using appropriate statistical methods (ANOVA and post-hoc tests).Results: Statistically significant differences (P < 0.05) were observed among the three tooth shape groups with respect to gingival angle, mesiodistal width-to-crown length (MDW/CL) ratio, and contact surface length (CS). Ovoid and square-shaped incisors showed particularly strong associations with CS and CS/CL ratios, while MDW/CL differed significantly across all groups.Conclusion: Tooth shape is significantly associated with variations in gingival angle, contact surface length, and the MDW/CL ratio. These findings support the use of tooth morphology as a reliable clinical indicator in esthetic treatment planning for restorative and prosthodontic procedures involving the maxillary lateral incisors
Linguistic comedy across contexts: Twain’s dialect, Leacock’s hyperbole, Narayan’s subtle irony
Get PDFThis research paper explores the nuanced deployment of linguistic strategies to generate humor inthe select works of Mark Twain, Stephen Leacock, and R.K. Narayan. Situated within a cross-cultural framework, the study investigates how each writer crafts a unique comic vision throughdialectal variation, hyperbolic expression, and understated irony. Drawing on representativetexts—Twain’s The Celebrated Jumping Frog of Calaveras County and Adventures of HuckleberryFinn, Leacock’s Sunshine Sketches of a Little Town and Arcadian Adventures with the Idle Rich,and Narayan’s Malgudi Days and The Guide—the paper undertakes a comparative textual analysisto identify linguistic markers that produce comic effect. The study is structured into five sections.The introduction situates the authors within their respective cultural and literary traditions,emphasizing the centrality of language in their humor. The literature review outlines key theoriesof humor, such as incongruity, superiority, and relief, alongside relevant studies in stylistics andsociolinguistics. The methodology section adopts a qualitative approach using discourse analysisand pragmatic tools, including Gricean maxims and speech act theory. The analysis and discussionsection examines how Twain’s use of regional dialect and idiomatic speech, Leacock’s satiricalverbosity and comic inflation, and Narayan’s minimalist irony reflect cultural specificity whileinvoking universal laughter. The conclusion synthesizes these findings, arguing that linguisticcomedy, though locally inflected, fosters transnational reader engagement and empathy.This papercontributes to humor studies, comparative literature, and stylistic analysis by foregroundinglanguage as a powerful medium of comic expression across literary cultures
A PRAGMATIC APPROACH TO COVID-19: A COMPREHENSIVE REVIEW OF THERAPEUTIC AND PREVENTIVE STRATEGIES
Get PDFThe outbreak of the novel coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has presented unprecedented challenges to global healthcare systems. Declared a pandemic by the World Health Organization on 11 March 2020, COVID-19 has disrupted routine clinical care and created specific concerns for patients receiving systemic immunotherapy, particularly for inflammatory skin disorders. This review synthesizes current evidence on immunomodulatory therapies in the context of SARS-CoV-2 infection, focusing on balancing treatment continuation with infection risk, immune response alterations, and the risk of flare-ups. Furthermore, we critically evaluate therapeutic strategies—including corticosteroids, Remdesivir, oxygen therapy—and address the limitations of unproven interventions such as hydroxychloroquine, ivermectin, and convalescent plasma. The review also discusses public health strategies, including early home-based management, vaccination, testing, and social behavior interventions, emphasizing their role in mitigating healthcare system overload. Based on evolving evidence, we provide practical recommendations for clinicians managing immunocompromised patients during the ongoing and future pandemics
PHARMACEUTICAL PACKAGING SAFETY: A REVIEW ON EXTRACTABLES AND LEACHABLES AND QUALITY ASSURANCE PRACTICES
Get PDFPharmaceutical packaging plays a leading role in the safety, stability and efficacy of drug products during their shelf life. However, substances known as extractables and leachables (E&L), which migrate from packaging material into the drug formulation, really compromise the good quality and safety for human life. This article reviews the different sources, types, and toxicological effects of E&L and the latest analytical techniques used for their detection, including GC-MS, UPLC-MS, and QTOF-LCMS. Various worldwide regulatory guidelines, including those of the USFDA and EMA, are discussed, with further emphasis on QA techniques to minimize contamination risks through risk-based approaches and adherence strategies. Real-life examples shall ultimately paint the picture in their application, highlighting actual issues. Consequently, limitations such as the lack of toxicological data and non-harmonized regulations will be tackled. With the promising safer and greener packaging systems, the emerging trends of greener materials and tamper-evident technologies shall also be weighed. This review tries to prove that pharmaceutical packaging needs a multi-disciplinary and internationally harmonized approach to ensure drugsafety and therapeutic efficacy
PEDAGOGICAL CONDITIONS FOR IMPROVING THE METHODOLOGICAL TRAINING OF FUTURE PRIMARY TEACHERS
Get PDFThe article talks about the content of improving the methodical training of future primary school teachers, some tasks and pedagogical conditions for its implementation
Factor influencing road kill mortality of birds: A review
Get PDFRoads exert several negative and adverse effects on the survival of various animals and ecosystem health, includingmortality, injury, habitat fragmentation, habitat isolation and enhancement of noise and chemical pollutants. These factorssignificantly affect wildlife survival, including that of avian species. Bird species such as scavenging raptors, corvids, andother insectivorous, granivorous and omnivorous species are attracted to roads for foraging and finding food resources.Birds drawn to roads are often startled by approaching vehicles, and such behavioral responses can result in bird fatalities.High speed and traffic volume also influence the mortality patterns of birds due to road vehicle collisions. Larger birds aremore susceptible to vehicle collisions than smaller birds
NANOTECHNOLOGY: EMERGING PROSPECTS, APPLICATIONS, AND INNOVATIONS
Get PDFNanotechnology operates at the scale of one-half the diameter of DNA to 1/20 the size of a red blood cell, offering unique
physicochemical properties such as increased surface area to volume ratio and enhanced reactivity. These characteristics
make nanoparticles particularly useful in diverse domains, especially biomedical applications including targeted drug
delivery, diagnostics, and imaging. This review highlights the synthesis, characterization, and biomedical implications of
metallic and metal oxide nanoparticles, emphasizing recent trends and eco-friendly synthesis routes like green synthesis.
The multifaceted nature of nanotechnology continues to open novel frontiers in science, medicine, and environmental
applications