Latest Articles

  • An Interview With Andreas Eschbach

    How has AI acceptance evolved in the pharmaceutical sector, and what strategies have been most effective in overcoming resistance to AI adoption? read more

  • Sustaining the Future of Life Science Product Research

    Few people say it outright, but the integrity of stored research and clinical samples underpins all scientific and medical progress. Every breakthrough drug, advanced therapy, or medical device depends on millions of biological, chemical, and physical samples that must be preserved intact across the entire product lifecycle. read more

  • An ADME Guide for Successful siRNA Therapeutics: Insights from Approved Drugs

    Small interfering RNA (siRNA) therapeutics have emerged as a trans formative class of drugs, offering targeted gene silencing capabilities that hold promise for treating various diseases. Since the landmark approval of the first siRNA drug Patisiran in 2018, the therapeutic siRNA landscape has expanded significantly, with multiple drugs, including Givosiran, Lumasiran, Inclisiran, and Vutrisiran, now approved in both the US and EU markets. Understanding these drugs’ absorption, distribution, metabolism, and excretion (ADME) characteristics is critical for optimizing their development and clinical application of siRNA therapeutics. read more

  • Challenges in Developing Analytical Procedures with the New ICH Q14 Guideline

    The current effective version of ICH Q14-Analytical Procedure Development was adopted on 1 November 2023. Development of analytical procedures under the new ICH Q14 guideline poses significant challenges yet also opportunities for the pharmaceutical industry. From analytical target profiles (ATP) to method lifecycle management, the guideline encourages a structured, risk-based approach that integrates Quality by Design (QbD) principles and analytical advancements into method development activities. Addressing these challenges effectively ensures robust, reliable, and compliant analytical procedures essential for drug development, regulatory approval, and global commercialization. This paper explores the critical aspects of method development and validation under the enhanced approach outlined in the Q14 guideline, emphasizing the key principles and expectations while highlighting strategies to navigate these complexities, optimize efficiency, and enhance pharmaceutical product quality and patient safety. read more