Utility of in vitro release testing (IVRT) to assess 'sameness' of 1% clotrimazole creams for use as a biowaiver

• Main Authors: Hannah Wellington (Author), Seeprarani Rath (Author), Sagaran Abboo (Author), Isadore Kanfer (Author)
• 格式: 图书
• 出版: SpringerOpen, 2023-11-01T00:00:00Z.
• 主题: article
• 在线阅读: Connect to this object online.

Abstract The October 2022 draft United States Food and Drug Administration (FDA) guidance presents an option of in vitro release test (IVRT) studies as a biowaiver for topical drug products submitted in abbreviated new drug applications (ANDAs). However, the product-specific guidance (PSG) for 1% cl...