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.
ASAPprime® protocols and software involve analysis of both temperature and RH effects on stability. ASAPprime® employs multi-dimensional analysis to more accurately and comprehensively estimate stability. The substance’s estimated shelf-life is achieved through a quantitative assessment of probabilities for passing under selected storage conditions. The advantage with ASAPprime® is that the scientist has a high degree of confidence that the conclusions drawn from the ASAP study will be scientifically supported.
ASAPprime® software provides a robust, science-based argument for choosing the optimal combination of packaging, formulation, ingredient supplier and manufacturing process without the need for repeated, lengthy and costly laboratory studies. Through accelerated stability modeling, ASAPprime® allows for better, more informed decision-making earlier in the development process, preventing costly reformulations and other changes throughout the product’s life-cycle.
Eliminate Package Screening
Now you can select packaging with sufficient confidence to eliminate package screening entirely. For many solid drug products, packaging provides protection from moisture; yet there is a trade-off between packaging cost and the degree of protection. With the Accelerated Stability Assessment Program (ASAP) and FreeThink’s ASAPprime® software, one can readily determine packaging that will provide an acceptable shelf-life for a product in any selected climate zone. The software can exactly predict the stability impact of the number and type of desiccants, number of unit dosage forms (i.e., number of tablets, capsules or amount of powder) and choice of excipients. In addition, the ASAPprime® software allows the user to balance moisture specifications with packaging choices. This provides a scientific basis for determining the impact of the initial moisture content and how it relates to the shelf-life in a QbD fashion.
No Surprise Reformulations
ASAP has proven to be a more accurate predictor of the true shelf-life for drug products and drug substances than real-time stability chambers. This is due to several factors, including the explicit accounting for moisture’s impact, and elimination of the assumption of linear degradation kinetics. ASAPprime® software eliminates the need for costly reformulations late in development, by providing confidence in the drug product stability.
When multiple lots of a drug substance or drug product are produced, stability variability can be determined with confidence using ASAPprime® software’s three-parameter fit. This comparison ability is especially useful when changes are made to the process, site, source material or excipients.
Insight into Manufacturing Issues
ASAPprime® can inform decisions on balancing the costs of drying to lower specifications versus using packaging with a higher degree of moisture protection. The software can also help companies confidently select packaging with different levels of moisture protection for different climate zones.
ASAPprime® helps make regulatory submission packages more robust by providing scientific rationale for decisions. In some cases, ASAPprime® study data has been successfully used in place of traditional long-term ICH studies for regulatory filings. While some countries have refused to consider the Accelerated Stability Assessment Program (ASAP), others have been more receptive. In general, this approach has been used to help speed new drug candidates into clinical trials more quickly. In many cases, contingency samples of clinical supplies were placed in chambers for analysis with data available for regulatory queries.
FreeThink successfully works with both large and small companies to increase the initially granted shelf-life at the time of registration for new products. In fact, one international pharmaceutical company recently reported that it was granted a three-year shelf-life at launch for a new drug product in the EU, using ASAPprime® analysis and just three months of traditional ICH data (with commitment for ongoing monitoring).
ASAPprime® data can also be used to:
Whether you are a first-time ASAPprime® user or a long-time customer, FreeThink can help with your regulatory strategy, and ensure a scientifically robust submission package based on ASAPprime® studies and data analysis.
ASAPprime® software can be used to determine the chemical stability of a wide range of substances from solids to liquids. This includes the following types of small molecules:
FreeThink licenses ASAPprime®, its proprietary accelerated stability software, to companies around the world in a variety of industries. Currently, 18 of the world’s 20 largest pharmaceutical companies use ASAPprime® or depend on FreeThink’s laboratory services to help solve some of their most difficult stability challenges.
Contact FreeThink Technologies, Inc. to learn more about licensing options, request a demo version of the software, or to schedule a live demonstration via WebEx®.