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Subsections (a) and (d) of 21 CFR 211.22 were specifically cited by the agency, demonstrating the emphasis the agency has placed on deficiencies in the functionality of quality units

Lipid peroxidation inhibition assay Reactive oxygen species induce membrane damage by peroxiding lipid moieties, particularly the polyunsaturated fatty acids in a chain reaction known as lipid peroxidation [31]

[DOI] [PubMed] [Google Scholar] [163].Niederreither K, Subbarayan V, Dolle P, Chambon P

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Final luminescence intensity value was normalised to DMSO median and surviving fractions of cells were plotted where lines of best fit were drawn using a four-parameter nonlinear regression

Lead time was close to what they estimated, which made planning easier