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5 articles for “Quality by Design (QbD)”
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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
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Innovative strategies in capsule formulation from concept to market
Abstract: Innovative strategies in capsule formulation have revolutionized drug delivery and nutraceutical development, offering advanced solutions from initial concept to market release. This report explores the transformative techniques at each stage of capsule formulation, detailing novel approaches in ingredient selection, encapsulation technology, and manufacturing processes. By leveraging advancements in artificial intelligence, encapsulation methods, such as liposomal and nanoparticle technologies, and materials science, formulators can optimize the bioavailability, stability, and targeted delivery …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 12, Issue 1, 2025 · pp. 1–8 Read article
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Recent Advances in Quality Control and Quality Assurance: Enhancing Pharmaceutical Product Integrity and Compliance
Abstract: The pharmaceutical industry is undergoing a paradigm shift driven by stringent regulatory expectations and the demand for high-quality, safe, and efficacious drug products. Quality Control (QC) and Quality Assurance (QA) serve as the two foundational pillars that ensure pharmaceutical integrity from raw material acquisition through to product release. Traditional QC and QA practices, while effective, have been challenged by complex formulations, biologics, and personalized medicine, requiring innovative methodologies and technologies. …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 2, 2025 · pp. 54–62 Read article
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Role of Pharmaceutical Software in Vaccine Development and Manufacturing Process Optimization
Abstract: Vaccine development and manufacturing have become increasingly complex due to the emergence of diverse vaccine platforms, stringent regulatory expectations, and global demand for safe and effective immunization. Across the vaccine lifecycle – from antigen design and preclinical evaluation to large‑scale manufacturing and post‑marketing surveillance – pharmaceutical software now plays a central role in handling data, optimizing processes, and ensuring regulatory compliance. Software tools support in silico antigen and epitope design, …
Published in International Journal of Vaccines · Vol. 3, Issue 1, 2026 · pp. 1–8 Read article
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Navigating the Horizon: Current Trends in Elevating Quality Assurance in Clinical Research
Abstract: The landscape of clinical research quality management has evolved significantly in recent years, driven by stringent regulatory frameworks and globalization of trials. This evolution underscores the importance of integrating quality into all aspects of the clinical trial process from design to postresearch activities. Concepts such as Good Clinical Practice (GCP) and Quality by Design (QbD) are central to ensuring the reliability and accuracy of trial data while safeguarding patient safety …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 11, Issue 1, 2024 · pp. 1–8 Read article