accelerated testing
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- 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.
- Related Term
- stability test
- storage conditions
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