Japanese–English glossary
Accelerated testing
Also called accelerated stability study
加速試験kasoku shiken
A stability study at conditions harsher than the storage conditions, mainly higher temperature, that speeds up chemical and physical change. Under ICH Q1A(R2), as applied in Japan, it supports shelf-life proposals and helps judge the effect of short excursions outside the label conditions, such as during shipping. When a significant change occurs under accelerated conditions, testing at the intermediate condition of 30 °C and 65% relative humidity is added. Accelerated data support, but do not replace, long-term data at the storage condition.