A big pharmaceutical company was planning to launch a new product and ultimately seek a three-year shelf-life in the US market (bottles with desiccant). The API degrades to give a primary degradation product by oxidation. Based on the daily dose, the default level of this degradant was originally 0.2%. The company wanted to know if this level was appropriate for the desired shelf-life, or if they should seek to qualify it to a higher level.
An ASAPprime® study was run which showed that the level at the end of three years (25°C/60%RH) was anticipated to be 0.22±0.04 (initial level of 0.1%).
Based on this, the company successfully worked to qualify the degradant to 0.30%. Interestingly, when the one-year data came in, the statistical projection incorrectly determined that the value at three years would be approximately 0.16%. Fortunately, the company had relied on the more accurate ASAPprime® study!