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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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Facts are stubborn things, but statistics are pliable. - Mark Twain Most people use statistics like a drunk man uses a lamppost; more for support than illumination. - Andrew Lang [...]
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Introduction and Background The storage of a bulk drug product is defined by the European Medicines Agency (EMA), with main reference to oral solid dosage forms (e.g., tablet cores before coating or packaging), but [...]
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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 Part 1 of this blog (Ref. 1) has described at a high level the guidance provided by the European Medicines Agency (EMA) on in-use stability testing of multi-dose products for human use (Ref. [...]
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Introduction and background The ICH stability guideline Q1A(R2) recommends to assess the stability of a drug product to be constituted or diluted before administration (e.g., a powder for injection) as well as after its [...]
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As projected in a Nov. 2020 StabilityHub release, Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued a new ordinance and an accompanying notification (explanatory document) about Japanese GMP’s on April 28, 2021. [...]
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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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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!
