2023
DOI: 10.1186/s41120-023-00087-4
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Utility of in vitro release testing (IVRT) to assess ‘sameness’ of 1% clotrimazole creams for use as a biowaiver

Hannah Wellington,
Seeprarani Rath,
Sagaran Abboo
et al.

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% clotrimazole (CLZ) topical cream does not provide an in vitro option for biowaiver and requires a clinical endpoint study to demonstrate bioequivalence (BE). Therefore, the main objective was to use IVRT to investigate pharmac… Show more

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