Q1A(R2) Stability Testing of New Drug Substances and Products — Step 4 (final); 6 February 2003 –Glossary
Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies. Data from these studies, in addition to long term stability studies, can be used to assess longer term chemical effects at non-accelerated conditions and to evaluate the effect of short term excursions outside the label storage conditions such as might occur during shipping. Results from accelerated testing studies are not always predictive of physical changes.
Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV — Withdrawn, definitions included here are from: WHO TRS 1010 2018, Annex 10 — Glossary
Studies designed to increase the rate of chemical degradation and physical change of an active pharmaceutical ingredient or finished pharmaceutical product by using exaggerated storage conditions as part of the stability testing programme. The data thus obtained, in addition to those derived from long-term stability studies, may be used to assess longer- term chemical effects under non-accelerated conditions and to evaluate the impact of short-term excursions outside the label storage conditions, as might occur during shipping. The results of accelerated testing studies are not always predictive of physical changes.
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