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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Detalhes bibliográficos

Principais autores:	Hannah Wellington, Seeprarani Rath, Sagaran Abboo, Isadore Kanfer
Formato:	Artigo
Idioma:	Inglês
Publicado em:	SpringerOpen 2023-11-01
coleção:	AAPS Open
Assuntos:	In vitro release testing (IVRT) Sameness Pharmaceutical equivalence Biowaivers Topical clotrimazole creams
Acesso em linha:	https://doi.org/10.1186/s41120-023-00087-4
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