You are invited to an AAPS Excipients Community Open Scientific Discussion on Excipient Nomenclature Guidelines Including Lipids and Polymers. Dr. Hong Wang, Senior Manager at U.S. Pharmacopeia (USP) will discuss the Excipient Nomenclature Guidelines released to public in 2023. Please check out the abstract and Dr. Hong's Bio.
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.
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
East Fallowfield PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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