ASAPprime® employs more advanced science and statistics than the “old fashioned” methodologies, enabling prediction of shelf-life and stability more quickly and accurately. ASAPprime lab studies are typically completed in as little as four weeks, with greater accuracy than traditional six-month studies. Since the ASAPprime® software explicitly determines the error bars of shelf-lives for each projected storage condition, the user can decide the level of confidence needed to proceed with the study. Typically, a confidence of >95% is acceptable. If the level of confidence is inadequate, more data (such as repeats, different storage conditions or packaging changes) will often increase the shelf-life projection confidence.
Retest periods can be determined in two to four weeks. These rapid tests not only provide a determination of the substance’s stability, but also allow for specification of storage conditions.
In most cases, initial use periods and product shelf-lives for drug products can be determined in two to four weeks. However, for some products, precise shelf-life determinations can require as much as six to eight weeks. For generic drug products, ASAPprime® software helps to quickly determine if the stability of the generic matches that of the comparator product.