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The effectiveness of quality control samples in pharmaceutical bioanalysis.
Stephen Keller1, Jorge Quiroz2, Dave Christopher3
1AbbVie, Inc., Redwood City, CA 94063, USA.
Bioanalysis
|February 4, 2021
Summary
Quality control (QC) samples in bioanalysis are essential for ensuring data accuracy. This study confirms that QC samples enhance pharmacokinetic data quality, justifying their continued use in drug development.
Area of Science:
- Bioanalysis
- Pharmacokinetics
- Pharmaceutical Development
Background:
- Quality control (QC) samples are standard in bioanalysis, aligning with regulatory expectations.
- A systematic evaluation of QC samples' impact on bioanalytical data quality was lacking.
- The Translational and ADME Sciences Leadership Group (TALG) initiated an assessment.
Purpose of the Study:
- To evaluate if QC samples improve pharmacokinetic data quality.
- To compare agreement between passed runs versus failed and passed (retest) runs.
Main Methods:
- Analysis of pharmacokinetic data across multiple organizations, molecular types, and analytical platforms.
- Comparison of data agreement between two passed analytical runs versus a failed and a passed (retest) run.
Main Results:
- Bioanalytical methods demonstrate high reproducibility.
- Closer agreement was observed when comparing data from two passed runs compared to failed and passed (retest) runs.
- QC samples demonstrably improve the overall quality of pharmacokinetic concentration data.
Conclusions:
- QC samples effectively enhance the quality of pharmacokinetic data.
- The findings support the continued utilization of QC samples in bioanalytical workflows.
- Bioanalytical methods are inherently reproducible, with QC samples providing an additional layer of data integrity.
Keywords:
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