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eBulletin  |  February 2014

Dedicated Individual Service - Unique Full Service Provider Focused on Early Stage Clinical Research

Eliminating Incurred Sample Reanalysis (ISR) Evaluation Failures

Algorithme Pharma has developed the Bioanalytical expertise to eliminate ISR evaluation failures by addressing key considerations in the early stages of method development. Our reproducible methods allow sponsors to meet the regulatory guidance requirements and avoid unnecessary repeat analyses.

Key Factors Addressed in Method Development
Drug Instability
Extensive research is completed for known drug instability in solution or in matrix to avoid unstable conditions during development.

To stabilize an analyte in solution and/or matrix, modifications to sample handling procedures may include sample extraction at 4°C, the addition of a preservative as well as storing the solution or matrix samples at the appropriate temperature.
Labile Metabolites
To optimize stability evaluations, our development approach includes labile metabolite(s) in Quality Control (QC) samples. Stability assessments include; short-term, long-term, freeze-thaw, processed reconstituted and whole blood.
Matrix Effects
For assurance of an acceptable ISR, it is critical to avoid matrix effect which is a major cause of ISR failure. We evaluate the matrix effect impact on analyte quantification over ten lots of matrices (male and female), one hemolyzed matrix and one lipemic matrix (as applicable). Late peaks are monitored and the ionization enhancement and/or suppression profile is evaluated by post-column infusion.

By developing high quality methods and establishing effective communication strategies, Algorithme Pharma delivers accurate and precise data for the reproducible quantification of therapeutic drugs in biological matrices.

Click here to submit your ISR question to our team of scientists.

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