Glossary

Time At Elevated Temperature (TAET) and Stability Budget

Also: TAET, stability budget

The cumulative time-out-of-range a product can tolerate against its stability data, tracked so each excursion draws against a finite budget.

A stability budget turns temperature control into a running balance rather than a pass or fail at each point, so a series of small excursions is assessed cumulatively.

It is grounded in stability studies under ICH guidance such as Q1A(R2) and Q5C.

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