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The effectiveness of quality control samples in pharmaceutical bioanalysis

Keller, Steve, Quiroz, Jorge, Christopher, Dave, Wickremsinhe, Enaksha , Geng, Wanping, Hawthorne, Glen, James, Christopher, Katterle, Yvonne, Li, Wenkui, Liu, Guowen, Mayer, Andrew, Paton, Martin, Pav, Joseph, Potter, Julian, Vergis, James and Wang, Jonathan (2021) The effectiveness of quality control samples in pharmaceutical bioanalysis. Bioanalysis, 13 (3). pp. 135-145. ISSN 17576199


The use of quality control (QC) samples in bioanalysis is well established and consistent with regulatory guidance. However, a systematic evaluation of whether QC samples serve the intended purpose of improving data quality has not been undertaken. The Translational and ADME Sciences Leadership Group (TALG) of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) conducted an evaluation to assess whether closer agreement is observed when comparing pharmacokinetic data from two passed runs, than when comparing data from failed and passed (retest) runs. Analysis of data collected across organizations, molecular types and analytical platforms, revealed that bioanalytical methods are very reproducible; and that QC samples improve the overall quality of pharmacokinetic concentration data and justifies their continued use.

Item Type: Article
Keywords: bioanalysis bioanalytical data quality failed runs QC failure QCs quality controls repeat runs sample retesting
Date Deposited: 30 Mar 2021 00:45
Last Modified: 30 Mar 2021 00:45


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