Lab glossary
Significant change (stability)
A change in a stability sample defined in ICH Q1A(R2) — for example a 5% loss of assay or a degradant over its limit. At accelerated conditions it triggers testing at the intermediate condition.
A change in a stability sample defined in ICH Q1A(R2) — for example a 5% loss of assay or a degradant over its limit. At accelerated conditions it triggers testing at the intermediate condition.