Post-preparative sample stability
Posted: Mon Dec 13, 2004 2:43 pm
Do people agree that the process of substantiating post-preparative sample stabilities, as per the FDA Guidance on Bioanalytical Method Development and Validation, in pharmaceutical quantitation assays require preparing a fresh standard curve to serve as the quantitative reference for each subsequent post-preparative sample stability experiment or would it be "good-enough" (Urk did I just say that) to establish quantitation integrity by comparing your first run to each subsequent post-preparative stability experiment and comparing means. 