In:
Bioanalysis, Future Science Ltd, Vol. 13, No. 3 ( 2021-02), p. 135-145
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1757-6180
,
1757-6199
DOI:
10.4155/bio-2020-0265
Language:
English
Publisher:
Future Science Ltd
Publication Date:
2021
SSG:
15,3
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