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4 articles for “Pharmaceutical Regulatory Agency (PRA)”
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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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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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Quality Control and Assurance Practices in Modern Pharmaceutical Industry
Abstract: This brief overview outlines the global techniques for figuring out the prevalence of geotaxis impurities (residual solvents and various inorganic and organic impurities) in medications. It is now necessary to reveal a pharmaceutical product's purity and impurity profiles due to both national and international regulations. These elements are discussed, together with the kinds of impurities, their origins, their control, and regulatory issues, as well as the significance of pharmaceutical quality, …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 3, 2025 · pp. 07–13 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