Latest Articles

  • HPLC-Based Strategies for Impurity Profiling and Validation in Standard Drug Analysis

    The control of pharmaceutical impurities is a fundamental objective in the development of drugs, focusing on the comprehension of the chemical structures of unidentified impurities. This understanding is essential for evaluating toxicological consequences and grasping the mechanisms of formation. API-related impurities, such as degradation and interaction, can affect drug product quality, safety, and efficacy. Classifying sources of impurities is essential for analytical method development and acceptance criteria. read more

  • Shore to Please

    As this year is coming rapidly to a close, I thought it might be interesting to review the ten biggest announced projects since January: read more

  • Future-Proofing Pharmacovigilance in an AI Era

    Clinical research organizations (CROs) are entering an era in which pharmacovigilance systems are doing more than just tracking copious amounts of data. They must also keep pace with evolving regulations, manage the growing volume of adverse event reports, and respond to heightened scrutiny from both regulators and the public. read more

  • Why DSCSA Compliance in 2026 Hinges on Execution, Not Implementation

    After a decade of ramp-up, the era of DSCSA enforcement is no longer theoretical — it’s here. But as we move deeper into this phase of full compliance, the real story unfolds not just in establishing data feeds, but in the operational cracks that persist behind the scenes. read more