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  • Post

    The 2023 PSDG Meeting was conducted within the KENX Laboratory University Event in San Diego, CA, May 9-11, bringing together dozens of Stabilitarians, Analysts, and Quality personnel to explore the latest challenges in the [...]

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    The 2023 PSDG Meeting was conducted within the KENX Laboratory University Event in San Diego, May 9-11, bringing together dozens of Stabilitarians, Analysts and Quality personnel to explore the latest challenges in the Stability [...]

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    Two years ago, eight medical product companies in Japan were found to have violations of GMP as well as the Japan Pharmaceuticals and Medical Devices Act. Enforcement has been public in Japan. Two companies have [...]

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    Stabilitarians and Stakeholders ask over and over; “What are effective measurements to evaluate a Stability Function?"; “How long should the various processes take?”; “How can you repair or eliminate problems of deviations, time over-runs, & [...]

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    What’s black and white, read all over, with lots of gray areas in the middle? That would be Stability regulations, guidances, the best of practices and the rest of practices. The gray areas are the [...]

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    Overview The 2022 Pharmaceutical Stability Discussion Group Meeting/KENX Laboratory University wrapped up on June 22 with participants in Philadelphia as well as virtually around the globe. The topics addressed included what’s new in the Stability [...]

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    This article will define the purpose of stability protocols, explore their potential elements, help us understand the impact of poorly designed protocols and learn how Stability Review Boards can assure optimal study design and improve [...]

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    The 2022 PSDG Meeting takes place live and virtually on June 20-22 in Philadelphia as the Stability track within KENX’s Laboratory University. PSDG selects the presentation topics and breakout sessions, while KENX produces the [...]

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    Earlier this year, a 2-part blog series on this website - Stability Testing Study Design and Data Evaluation to Support a Clinical Study in the European Union - reported points to consider when designing a [...]

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    Introduction ANVISA, the Brazilian human health regulatory authority, has issued in the recent years a number of documents describing in detail what is expected to be presented on Forced Degradation Studies and how they [...]

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A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!