Quality by Design
4 articles · search the full text for this term
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Digital Enablers of Nanomedicine: Pharmaceutical Software Across the Lifecycle of Nanotechnology‑Based Drug Products
Abstract: Nanotechnology‑based drug products have rapidly evolved from laboratory concepts to clinically relevant therapies, yet their development is constrained by complex design variables, stringent quality requirements, and emerging regulatory expectations specific to nanomaterials. Pharmaceutical software now plays a central role in the nanomedicine lifecycle, enabling in silico design of nano‑carriers, simulation of nano–bio interactions, control of nanoscale quality attributes during manufacturing, and systematic tracking of safety signals in real‑world use. Integrated …
Published in Nano Trends – A Journal of Nano Technology & Its Applications · Vol. 28, Issue 1, 2025 · pp. 11–16 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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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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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