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April 25th AAPS Excipient Community Scientific Discussion: Excipient Nomenclature Guidelines

  • 1.  April 25th AAPS Excipient Community Scientific Discussion: Excipient Nomenclature Guidelines

    Community Leadership
    Posted 04-10-2024 10:12
      |   view attached

    Dear all,

       AAPS Excipient Community has invited Dr. Hong Wang, Senior Manager at U.S. Pharmacopeia (USP) to give a talk on the Excipient Nomenclature Guidelines released to public in 2023. Please check out the abstract and Dr. Hong's Bio. We welcome everyone who's interested to join us in the discussion. Look forward to seeing you!

    Presentation Title: Excipient Nomenclature Guidelines

    Abstract:

    This presentation will introduce the USP Excipient Nomenclature Guidelines released to the public in March 2023 and is the first USP nomenclature guidelines for excipients. Topics covered include the guideline' outlines, excipient classifications, the definition of excipient component, and will further focus on two specific areas, nomenclatures for lipids and polymers which are multiple component-based excipients. With applications of more advanced analytical techniques for lipids and polymers, appropriate naming can be assigned in the USP/NF. Additionally, this discussion will delve into how the guidelines help align the names in USP/NF standards, FDA inactive ingredient database, and the FDA global substance registration system; address FDA's Q1 sameness requirements for complex generics to indicate excipient types in meeting the needs of complex generics and innovative therapeutics; and to guide stakeholders to understand excipient composition and profiles.

    Best regards,

    Jiaying (Ingrid) on behalf of AAPS Excipient Community LT

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    Jiaying Liu
    Senior Scientist
    Merck & Co, Inc - Rahway, NJ
    Kenilworth NJ
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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