A pharmaceutical company used regression to assess the stability of the active ingredient in a drug to predict its shelf life in order to meet fda regulations and identify a suitable expiration date for the drug.
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The expiry date is that point in time when a pharmaceutical product is no longer within acceptable specifications for potency and stability. In determining an expiry date, a range of characteristics of the product are studied over time. One important characteristic is the chemical stability of the active ingredient. Temperature has a pronounced effect on the rate of degradation of the active ingredient. As the rate of decomposition usually doubles for every 100C rise in temperature, it is important to comply with the storage conditions specified on the container. The expiry date may be set as a fixed time after manufacture, dispensing or opening of the manufacturer's container. It is good practice not to use drugs past their expiry date.