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Have you developed User Requirements for your Stability Training? Seems like an unusual place to apply them, but we all have training needs across unique sets of people and practices. See what might be [...]
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The goal of Medical Product Stability Day is to recognize the process, as well as the scientists who work with a small army of stakeholders to conduct the experiments to determine the stability of medical [...]
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Significant changes are in the works for our favorite guidelines, and you can be part of the process! The ICH Stability Working Group’s (SWG) final concept paper Targeted Revisions of the ICH Stability Guideline [...]
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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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They say it takes a village to raise a child, and not too-ironically, it also takes a village to run a Stability program. Today's article explores the Stability Village and the people Stabilitarians need to [...]
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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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A quote from a Bob Dylan song that used to adorn a poster on my wall is “He not busy being born is surely busy dying”. That observation has a wide application and certainly applies [...]
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Each pharmaceutical, biological, medical device, vaccine, and cell therapy company employs or contracts scientists who subject the product to a range of temperature, humidity, and light over a period of time, test the product periodically [...]
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Perennial conference presentations about regulatory citations (483’s & Warning Letters in the US) often show Stability Function citations in the Top 10 list. A contributing factor to keeping Stability a permanent resident in the Regulatory [...]
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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!
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!
