Pharma Success Story

Challenge

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.

 

FreeThink’s Approach

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%).

 

Results

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!

 

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