Validation of a Size-Exclusion Chromatography Method for Bevacizumab Quantitation in Pharmaceutical Preparations: Application in a Biosimilar Study
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DOI: 10.3390/separations6030043
Abstract: In May 2019, the Food and Drug Administration (FDA) proposed a quality range (QR) method for the comparative analytical assessment in biosimilar studies. In this process, several reference product lots are necessary, selected from a… read more here.
Keywords: validation size; lots variation; reference product; method ... See more keywords