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Cosmetics are different, yet similar to pharmaceutical formulations in that they’re susceptible to temperature, humidity, light, and microbial contamination. An unstable cosmetic can no longer fulfill its mission in creating a better appearance. As in [...]
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May was Stability Information Month, and the information sources did not disappoint. This month’s (June 2024) Newsletter carries the hot topics that emerged from StabilityHub’s Office Hours, the PSDG Meeting at KENX’s Laboratory University [...]
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What did the pharmaceutical world do for photostability before ICH Q1B came along in 1996? Undoubtedly, to mimic real world light exposure situations our scientists used dependable scientific method and justified their protocols sensibly. Research [...]
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There are two updates proposed in Japanese regulations regarding changes. The first is the substitution of analytical methods and the other concerns post-approval change control. In addition, there seems to be a recent change [...]
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When assembling a Stability Program, right after a QC laboratory and stability chambers, a Statistics plan would be high on our list. Whether we have one now, contract it out or are planning for the [...]
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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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Wow, I have to say, ChatGPT is amazing after using it for the first time, just now. I didn’t write this with AI, but I did play around with it to see what it [...]
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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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Since China has applied for PIC/S pre-accession in September 2021, interest in adopting PIC/S GMPs is growing. Descriptions in Chinese GMPs and the Chinese Pharmacopoeia sometimes differ from PIC/S GMPs or the ICH Quality [...]
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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!
