Method Development & Validation

Frontage uses a streamlined and compliant approach to developing and validating bioanalytical methods for both small and large molecules. For most small molecules, Frontage has been highly successful in developing methods within one to two weeks of project start-up with validations complete within two to three weeks.

 

Frontage evaluates the following factors in developing robust bioanalytical methods:

  • Signal response

  • Chromatography conditions (column, mobile phase, flow rate, etc.)

  • Matrix effects and interference, sample preparations

  • Analyte affinities

  • Sensitivity (LLOQ & LOD)

  • Linearity range

  • Stability

The following method parameters are typically verified during validations:

  • Specificity

  • Sensitivity (LLOQ)

  • Extraction recovery

  • Linearity range (calibration curve)

  • Accuracy (intraday/interday)

  • Precision (intraday/interday)

  • Dilution integrity (above quantitation limit)

  • Bench-top stability

  • Freeze-thaw stability

  • Processed sample stability

  • Long term storage stability

  • Standard stock solution stability at RT

For a complete list of Frontage’s nonproprietary bioanalytical methods, please click here