ICH Q14: An Enabler for Analytical Procedure Lifecycle Which Ensures Robustness of Analytical Methods During a Drug’s Lifetime

Description:
One goal for analytical procedures that support a drug is the ability to ensure that the method is fit for purpose and consistently delivers its intended control. Many new drugs are developed on accelerated timelines. In some cases, clinical studies are combined, and an investigational drug may go from first in human studies to commercial approval in just a few years. In these cases, the time allotted for CMC development is significantly reduced, and there may not be enough time/experience with analytical methods to define robust long-term method conditions. This increases the risk of the need for post approval changes to analytical methods. Several principles within the developing ICH Q14 draft guidance may enable faster method changes to advance method robustness and/or efficiency within the required regulatory control framework. A specific example will be shared to demonstrate how the principles of Q14 may be applied to enable lifecycle changes and hence improve method robustness which has the overall benefit of ensuring drug supply continuity.

Speaker: Cindy Hammill - Eli Lilly and Company