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9 articles for “GMP”
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A Comprehensive Exploration of Method Validation and Development in Pharmaceutical Analysis: Focus on Vortioxetine Analysis
Abstract: The pharmaceutical industry relies on rigorous method validation to ensure the accuracy, precision, and reliability of analytical techniques employed in drug testing and quality control. This comprehensive exploration delves into the validation parameters and guidelines essential for method validation, emphasizing accuracy, precision, linearity, detection and quantitation limits, specificity, range, robustness, and ruggedness. Validation plays a pivotal role in guaranteeing high-quality products, adhering to good manufacturing practices (GMP), and optimizing manufacturing …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 46–52 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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Toxicological Profiling and Safety Assessment of NASAT 2.0: A Conceptual Framework for Adaptive Nanoparticle Therapy in Rabies
Abstract: Rabies, caused by the highly neurotropic Rabies lyssavirus, remains one of the most enigmatic and universally lethal infectious diseases known to modern medicine. Once clinical symptoms manifest following successful neuroinvasion, the fatality rate approaches absolute certainty (approximately 99.9%), a staggering statistic that has remained largely unchallenged despite massive, concurrent advances in modern virology, critical care medicine, and cellular immunology. Current late-stage therapeutic protocols, most notably the widely debated Milwaukee Protocol, …
Published in Research and Reviews: A Journal of Toxicology · Vol. 16, Issue 2, 2026 · pp. 1–19 Read article
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A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India
Abstract: A major regulatory change in pharmaceutical manufacturing industry in India is the introduction of the updated Schedule M (2023–2024). The aims to compliance the country's Good Manufacturing Practices (GMP) with international quality standards. The review evaluates the Schedule M amendments implementation strategies, industrial impact and regulatory relevance. Legislative texts, official notices, WHO GMP reports, ICH guidelines, guidance documents of CDSCO and peer-reviewed literature were all explored as part of the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 2, 2026 Read article
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Revamping of Pharmaceutical Manufacturing Processes
Abstract: The pharmaceutical sector is entering a new era marked by technological advancements and an emphasis on sustainability and efficiency. A commitment to compliance can help boost consumer confidence and regulatory approval. This abstract explores the multifaceted approach to revamping pharmaceutical manufacturing processes, encompassing technological integration, regulatory compliance, and sustainability initiatives. Technological advancements, including automation, data analytics, and artificial intelligence, are playing a pivotal role in streamlining manufacturing operations. These innovations …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 38–44 Read article
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Seismic Hazard Evaluation through Attenuation Law Derivation and Response Spectrum Design: Bangladesh Case Study
Abstract: Bangladesh, positioned at the confluence of the Indian, Eurasian, and Burma tectonic plates, faces significant seismic hazards due to its complex geological setting. This research focuses on formulating empirical attenuation relationships and Creating a design response spectrum for assessing seismic risks in Bangladesh, using data from ten large earthquakes with magnitudes ranging from 6. 7 to 7. 9. The study creates Ground Motion Prediction Equations (GMPEs) for various structural periods …
Published in Journal of Structural Engineering and Management · Vol. 12, Issue 3, 2025 · pp. 54–63 Read article
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Outward Material Storage Area and Dispensing Activity for Packaging Material Area
Abstract: Efficient management of outward material storage and packaging material dispensing is essential for maintaining product quality, regulatory compliance, and streamlined operations in manufacturing industries. This review examines the principles, practices, and challenges associated with the design, organization, and control of outward material storage areas, with a specific focus on packaging material handling. Key aspects discussed include layout optimization, material segregation, environmental controls, documentation practices, and adherence to Good Manufacturing Practices …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 1, 2026 · pp. 27–32 Read article
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A Review on Transforming Patient Pathways: The Impact of Pharmaceutical Software on Drug Manufacturing and Safety Monitoring
Abstract: The development, production, and safety monitoring of pharmaceuticals are being revolutionized by incorporating digital technologies. Throughout drug lifecycles, pharmaceutical software which includes cloud-based systems, automation, data analytics, and artificial intelligence (AI) has emerged behind efficiency and innovation. Real-time monitoring, predictive maintenance, and process optimization are made possible in manufacturing by software tools like Digital Twins, Manufacturing Execution Systems (MES), and Quality Management Systems (QMS). These technologies improve batch consistency, lower …
Published in Emerging Trends in Personalized Medicines · Vol. 3, Issue 1, 2026 · pp. 40–46 Read article
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India’s Traditional Medicine Trade (2015–2024): Trends, Regulatory Landscape, and Policy Directions for Sustainable Growth
Abstract: India is a major global supplier of traditional medicine products – including Ayurvedic, Unani, Siddha, homeopathic, and other herbal and plant-based formulations – yet exports continue to face challenges arising from regulatory divergence, heterogeneous quality-control requirements across markets, and raw-material supply constraints linked to biodiversity pressure and fragmented value chains. This paper systematically analyzes India’s import-export patterns for traditional medicine between 2015 and 2024, maps the regulatory landscape (DGFT, Drugs, …
Published in Research & Reviews : A Journal of Unani, Siddha and Homeopathy · Vol. 13, Issue 1, 2026 · pp. 13–18 Read article