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. This increases the risk of the need for post approval changes to analytical methods.
In this talk we will review how the principles of ICH Q14 may be an enabler for speeding these method changes. We will leverage a specific example 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.
Executive Director Synthetic Molecule Design & Development,
Eli LIlly & Company
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