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With apologies to Trekkies and Warriors of the Star variety...In the Stability Universe, we have pretty good control over our ship. We can train and order our crew to maintain and pilot the Stability Group [...]
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Ensuring the integrity of stability studies is the primary driver for nearly all logistical activities of a stability program. People, programs, and paper hold the links together in the stability chain of custody—a process as [...]
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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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Japanese Good Manufacturing Practices (JGMP) have undergone some modifications since the previous round in August 2021. At the November GMP/GQP research meeting between the Pharmaceuticals and Medical Devices Agency and three state authorities, recent [...]
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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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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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Following the April 28, 2021 Japanese GMP ordinance outlined in a previous StabilityHub Newsletter, further rules and regulations contained in the Japanese Pharmaceutical and Medical Device Act were initiated on August 1, 2021, For [...]
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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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Many of today’s pharmaceutical formulations, to some degree, are sensitive to oxidation. Besides a loss of efficacy and reduction in shelf life, exposure to oxygen can result in product discoloration, toxicity, or other pharmacological [...]
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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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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!
