Drug stability studies, Advanced Statistics

The studies conducted in the pharmaceutical industry to calculate the degradation of the new drug product or an old drug formulated or packaged in the new manner. The main study objective is to estimate the drug's shelf life, defined as the time point where the 95% lower confidence limit for regression line crosses the lowest acceptable limit for the drug content according to Guidelines for Stability Testing. 

Posted Date: 7/27/2012 6:33:06 AM | Location : United States







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