Latest Articles

  • Executive Q&A - A Strategic Acquisition: Insights and Ideas

    An interview with Brian Morrissey, General Manager of Gaelic Laboratories, which has acquired Athlone Laboratories in a strategic deal that typifies the current pharma M&A landscape and puts all of Ireland’s Beta-Lactam manufacturing capacity under one ownership umbrella. read more

  • The Dog Days of Summer

    As I write this in the middle of August, during an oppressively humid heat wave, the term “the dog days of summer” comes to mind. If you have never heard that term, it refers to the hottest, most stifling period of summer. Quite apropos, as we are currently experiencing a heat wave. But where did the term come from? read more

  • Optimizing Product Packaging and Oral Drug Delivery with Stick Packs

    In the ever-evolving world of pharmaceutical science, innovation in drug delivery systems often drives improvements in patient adherence, therapeutic efficacy, and manufacturing efficiency. One such innovation gaining momentum is stick pack technology, a flexible single-use packaging format. It offers an alternative approach to delivering oral dosage forms that can better align with patient needs and preferences. 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