The effectiveness of quality control samples in pharmaceutical bioanalysis

Keller S, Quiroz J, Christopher D et al. | Bioanalysis. 3(13), 135–145 (2021). Keywords: bioanalysis • bioanalytical data quality • failed runs • QC failure • QCs • quality controls • repeat runs • sample retesting 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...