European Bioanalysis Forum: recommendation for dealing with internal standard variability

Area of Science:

• Analytical Chemistry
• Bioanalysis
• Pharmaceutical Analysis

Background:

• Internal standard (IS) response monitoring is essential for analytical run integrity.
• Current practices for assessing IS response variability lack standardization across laboratories.
• The European Bioanalysis Forum (EBF) identified a need for best practice guidelines.

Purpose of the Study:

• To survey current practices for monitoring internal standard response variability within EBF member companies.
• To identify common challenges and approaches in managing IS response deviations.
• To recommend a standardized, best-practice approach for assessing IS response in bioanalytical runs.

Main Methods:

• A survey was distributed to European Bioanalysis Forum member companies to gather data on their internal standard monitoring practices.
• Data analysis focused on identifying trends, common methodologies, and areas of divergence in IS response assessment.
• A topic team was formed to review survey results and formulate recommendations.

Main Results:

• Significant variation exists in the methodologies employed for monitoring internal standard response across different laboratories.
• Commonly identified anomalies in IS response include drifts, shifts, and outliers.
• A consensus emerged on the need for a more harmonized approach to IS response evaluation.

Conclusions:

• Standardized monitoring and assessment of internal standard response are critical for reliable bioanalytical data.
• The EBF recommends the adoption of a consistent, best-practice approach to manage IS response variability.
• Implementing these recommendations will enhance data quality and inter-laboratory reproducibility in bioanalysis.