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To quantify the rescue effect of MCC950 or BFE treatment on NLRP3 activation, the percentage rescue was calculated relative to the activated positive control (LPS+nigericin) condition

[DOI] [PMC free article] [PubMed] [Google Scholar] 151.Qian Y, Dai H, Li H

doi: 10.1186/s12943-020-01247-w 117 JiangMChenPWangLLiWChenBLiuYet al

The FDA keeps citing firms that fail to demonstrate: Insufficient evidence of process control Validation executed with incomplete protocols Cleaning validation skipped or outdated CAPAs closed without demonstrating actual effectiveness This is where scientific justification and documentation need to work hand in hand

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