ASAPprime®Overview Video – An introduction to ASAPprime® software
ASAPprime® v.5. – New features and benefits of the ASAPprime® software v.5.
What is ASAPprime® ? – An overview of the science behind ASAPprime® software.
Introduction to ASAPdesign™ – ASAPdesign™ helps scientists plan the most efficient scientific and statistical design for carrying out an ASAPprime® study.
ASAPdesign™, a feature of the ASAPprime® software package, guides the user on how to set up the
appropriate conditions and time-points to get optimal results. The program uses a number of factors,
including the type of product being studied –in this example a tablet.
ASAPprime® studies take accelerated degradation data to model long-term behavior. The program helps
balance the amount of sample analyses one does (more is always better statistically), the error bars and the
time the user is willing to wait for results (Limit of Patience).
Phase boundaries represent limits on the design space for the accelerated aging. The program guides users
through such considerations. In this case, the active is assumed to be amorphous with a glass transition
temperature of 114C. ASAPprime® estimates the depression of this value as a function of relative humidity.
ASAPprime®designs aim to determine the isoconversion time (time to hit the failure point) at each condition.
With prior knowledge, better designs are possible. Any previous data available can help to improve the study
design with use of ASAPdesign™.
ASAPdesign™ came up with the indicated design, including nine conditions with time points ranging from 1-21 days. Designs with higher relative humidities
were avoided due to the glass transition temperature given.
In this example, degradant levels are reported at each condition and time point. The probability of passing
stability specifications with the tablets packaged in HDPE bottles (30 tablets in a 60 cc bottle) stored at
25°C/60%RH for 3 years is 99.5%.
The same product at a harsher climate zone (Zone 4b), now has only an 81.7% probability of passing at just
2 years (usually want >95% probability of passing).
Adding 1g of silica gel desiccant now allows the product to have 99.4% probability of passing at 3 years in the Zone 4b climate.