传统的货架寿命评估包括:延伸货架寿命研究(extended shelf-life study)、加速货架寿命试验(accelerated shelf-life test)。 注意:延伸货架寿命研究结果较准确,但耗时较常;加 速货架寿命试验虽然耗时短,但准确性差。
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Shelf Life Accelerated Test 货架期加速试验
Objective: to predict the stability of lyophilized human thrombin by estimating the shelf life at different temperatures through accelerated storage test.
目的:为了在短时间内了解凝血酶的稳定性,通过加速试验对人凝血酶在不同温度下的贮存寿命进行了估算。
METHODS Accelerated test classical constant temperature method, and multi-variation linear model were used to estimate shelf life.
方法 :采用加速试验 ,经典恒温法和多元线性模型预测其有效期。
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