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

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

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...

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Bibliographic Details
Main Authors: Hannah Wellington, Seeprarani Rath, Sagaran Abboo, Isadore Kanfer
Format: Article
Language:English
Published: SpringerOpen 2023-11-01
Series:AAPS Open
Subjects:
In vitro release testing (IVRT)
Sameness
Pharmaceutical equivalence
Biowaivers
Topical clotrimazole creams
Online Access:https://doi.org/10.1186/s41120-023-00087-4

Internet

https://doi.org/10.1186/s41120-023-00087-4

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