How is the Labeled Shelf Life for a drug defined according to stability working groups?

Answer

The shorter of the supported shelf life and the maximum shelf life.

The labeled shelf life on a pharmaceutical product represents the final, practical commitment regarding quality assurance and stability. This date is calculated by taking two specific estimates derived from stability data and regulatory constraints, and choosing the more conservative measure. Specifically, the supported shelf life, which is a statistically conservative estimate of the true product shelf life, is compared against the maximum shelf life, which is a regulatory limit defined by extrapolation guidelines, such as those found in ICH Q1E documentation. The labeled shelf life is established as the shorter duration between these two calculated values, ensuring that the product adheres to both statistical projection and regulatory allowance for extrapolation.

How is the Labeled Shelf Life for a drug defined according to stability working groups?

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