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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| Main Authors: | , , , |
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| Format: | Book |
| Published: |
SpringerOpen,
2023-11-01T00:00:00Z.
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| Online Access: | Connect to this object online. |
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