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  • Featured Paper: Predicting the Tabletability of Binary Mixtures from Individual Powder Compaction Behavior (International Journal of Pharmaceutics, 2026. DOI:10.1016/j.ijpharm.2026.126690) Background Developing a direct compression tablet ...

  • Dear Members VERY IMPORTANT ( The LAST DATE OF SUBMITTING COMMENTS IS JULY 13, 2026.) Please note FDA by a Notice on 03/03/2026 announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances ...

  • A group of folks suggest forming a team focussing on "Excipients and supply chain controls". Since many of the members of our community are working in this area, I am very excited to start this team up and initiate a few activities in this area. What ...

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    Drug Coated Device Review Articels

    Ahead of our upcoming July 21st Webinar titled "Rethinking Formulation for Drug-Coated Medical Devices", please consider reviewing the below linked articles to learn about coating challenges of medical devices. Drug-Eluting Stents: Technical and ...

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    Drug Coated Device Review Articels

    Please join us for our upcoming Webinar, titled "Rethinking Formulation for Drug-Coated Medical Devices" on July 21. Ahead of the Webinar, here are some helpful review articles describing the challenges of coating medical devices. https://science360.aaps.org/science360/2026/webinars/4206437/faculty.presenters.rethinking.formulation.for.drug-coated.medical.devices.html?f=menu%3D24%2Ac_id%3D4206437%2Afeatured%3D20109%2Ashow_banner_in_top_panel%3D1 ...

  • Starting this Friday (June 26), Regulatory Science Community meetings move to AAPS Science 360. You'll sign in and register each month, and we'll post the topic and speaker as a reminder. We meet every month on the 4th Friday, 12–1 p.m. ET. This month, ...

  • USP has published four draft analytical method standards for biologic products and opened them for early stakeholder input - ahead of the formal compendial process . This pre-official window is a meaningful opportunity to help shape these methods before ...

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    PAT and Process Modeling Subteam

    Dear MSE and AAPS community members, Are you c urious about how AI/ML and PAT can reshape process development and manufacturing? Come join us! This focus group is a space to share ideas, tackle real challenges, and explore practical applications across ...

  • The submission deadline for Rapid Fire presentations at AAPS PharmSci 360 is coming up on June 12 at 5:00 PM ET . If you're planning to participate, now is a great time to review the Rapid Fire guidelines and prepare your materials for ...

  • Dear MSE Community Members, With the growing interest in AI and Digital Twin technologies across CMC and pharmaceutical manufacturing, I'm interested in learning how different organizations are implementing these models and preparing them for regulatory ...