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8 articles for “regulatory agency requirements”
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The Contribution of A. I. in Pharmaceutical Software
Abstract: The integration of Artificial Intelligence (AI) in pharmaceutical software has significantly transformed drug development, regulatory processes, and clinical management. AI-powered tools are revolutionizing data analysis, predictive modeling, and decision-making, enhancing the efficiency and accuracy of drug discovery and development. This article explores the multifaceted contributions of AI to pharmaceutical software, including its applications in drug screening, personalized medicine, clinical trial optimization, and regulatory compliance. Additionally, we examine how AI is …
Published in International Journal of Biomedical Innovations and Engineering · Vol. 3, Issue 1, 2025 · pp. 1–10 Read article
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Review article on Quality Control in Clinical Trials
Abstract: Quality control (QC) is a critical component in the conduct of clinical trials, ensuring the accuracy, reliability, and credibility of data collected throughout the study. It encompasses a systematic set of procedures designed to monitor trial conduct and data integrity, thus safeguarding the rights, safety, and well-being of participants. This review explores the principles, implementation, and evolving practices of quality control in clinical trials, highlighting its importance across all phases …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 12, Issue 3, 2025 · pp. 01–07 Read article
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Drone Safety Protocols Developing and Implementing Safety Procedures
Abstract: The increasing utilization of drones across various sectors, including agriculture, logistics, surveillance, and recreational activities, necessitates the establishment of robust safety protocols to mitigate risks associated with their operation. This study explores the development and implementation of comprehensive safety procedures for drone operations, focusing on both regulatory compliance and technological advancements. The study emphasizes how crucial it is to comprehend the legal frameworks set forth by aviation authorities, including the …
Published in International Journal on Drones · Vol. 1, Issue 1, 2025 · pp. 44–49 Read article
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Regulatory Requirements for Pharmaceutical Product Registration in Zambia
Abstract: There is a significant burden of diseases in Zambia and its neighboring countries, such as malaria, HIV/AIDS, and other ailments. These health challenges necessitate a high consumption of pharmaceutical products. Currently, the majority of essential health drugs in Zambia are imported from outside of Africa. This reliance on external sources presents an opportunity for new investments in the local manufacturing of pharmaceutical products. Although Zambia may not be the largest …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 2, 2024 · pp. 33–41 Read article
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Understanding the Impact of GMO on Hormones and Their Effect on Mood: A Review Paper
Abstract: The research evaluates how consuming genetically modified organisms affects endocrine functioning that can potentially lead to mood changes or disorders. This is a systematic review paper that analysed sixty publications before selecting thirty which were obtained from Sciencedirect, Frontiers, Springer, Oxfordacadamic, Cabidigitallibrary, Wileyonlinelibrary, Cambridgeuniversitypress, Scijournals, Mdpi, Metabolismjournal; while using Prisma Flow Diagram as the research tool; acknowledging that human hormonal health risks from GMO consumption remain largely unknown due to …
Published in Research & Reviews : Journal of Food Science & Technology · Vol. 14, Issue 3, 2025 Read article
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Kisunla (Donanemab): A Novel Breakthrough Illuminating a Path to Better Alzheimer’s Outcomes
Abstract: Background: Alzheimer’s disease (AD) is a progressive neurodegenerative condition marked by cognitive decline, memory loss, and loss of independence. Despite decades of extensive research, disease-modifying treatments have been limited in success. Recent therapeutic advancements have led to the development of monoclonal antibodies targeting amyloid-beta (Aβ) plaques, particularly the pyroglutamate-modified variant, a key pathological hallmark of AD. Objectives: This review aims to explore the therapeutic potential of Donanemab (Kisunla), a novel …
Published in Research and Reviews: A Journal of Neuroscience · Vol. 15, Issue 3, 2025 · pp. 37–45 Read article
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Towards a Safer Nuclear Future: Safety, Security, and Proliferation
Abstract: The worldwide spread of nuclear technology creates both possibilities and hazards, thereby requiring a thorough strategy for nuclear safety, security, and non-proliferation. This paper looks at the linked issues of stopping nuclear accidents, protecting materials from nefarious use, and controlling the proliferation of nuclear weapons. It investigates the efficacy of treaties like the Nuclear Non- Proliferation Treaty (NPT) and looks at international regulatory systems, including those run by the International …
Published in Journal of Nuclear Engineering & Technology · Vol. 15, Issue 2, 2025 · pp. 34–47 Read article
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Implementing Quality by Design (QbD): Strategies, Challenges, and Best Practices across Industries
Abstract: The present comprehensive review investigated the dynamic landscape of quality standards within the pharmaceutical sector, with a primary focus on the implementation and impact of Quality by Design principles. It illuminated the multifaceted challenges encountered by pharmaceutical companies in upholding stringent quality standards amidst evolving regulatory requirements and complex manufacturing processes. By embracing Quality by Design principles, the industry aims to foster a proactive and systematic approach to product development …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 2, 2024 · pp. 28–36 Read article