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:
Precision (repeatability, intermediate precision)
Detection Limit (DL)
Quantitation Limit (QL)
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.