Method Qualification

Cytovance can qualify analytical methods to be used for in-process or release testing, according to parameters described in the ICH guidelines Validation of Analytical Procedures: Text and Methodology Q2 (R1). Qualification parameters may include:

  • Accuracy

  • Precision (repeatability, intermediate precision)

  • Specificity

  • Detection Limit (DL)

  • Quantitation Limit (QL)

  • Linearity

  • Range

Method Validation

The Cytovance analytical team can validate required analytical methods using reference standard and a testing matrix. The methods must produce results as outlined in the validation protocol.