Utility of in vitro release testing (IVRT) to assess ‘sameness’ of 1

Hannah Wellington,Seeprarani Rath,Sagaran Abboo,Isadore Kanfer

AAPS Open（2023）

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摘要

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

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关键词

In vitro release testing (IVRT),Sameness,Pharmaceutical equivalence,Biowaivers,Topical clotrimazole creams

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