Yes, I think that the enhanced approach is an incentive to use software-assisted method development. Pieces of software are already used to automate, eg, LC optimisation or to automatically cover robustness designs; ICH Q14 will make these approaches all the more relevant.

Join Dr. Cyrille Chéry (UCB) to learn more about Critical Analytical Procedure Parameters and Risk Assessments.

Watch the On-Demand presentation now: https://bio-qc.com/critical-analytical-procedure-parameters-and-risk-assessments/  

Plus, don’t miss his expert insights during the panel discussion on Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development.