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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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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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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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Introduction ANVISA, the Brazilian human health regulatory authority, has issued in recent years a number of documents describing in detail what is expected to be presented in a Regulatory submission in Brazil for Forced [...]
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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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This blog post is Part 1 of the series and comes to us from Piero De Filippis, StabilityHub EU Regional Contributor, Verona (Italy). Part 1: Stability Study Design for an Investigational Medicinal Product European [...]
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The 2020 PSDG Virtual Meeting wrapped up on November 17th. Emerging from the three days of sessions was a glimpse into the not too distant future of the stability function. Technology and world events [...]
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This would be a great season to measure your stability function against the provisions of the ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes. Guest [...]
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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!
