Accelerated stability modeling for difficult cases when nothing happens or degradants degrade

Conclusion Statement: • Two challenging situations for accelerated aging examined • Assigning a minimum shelf-life when nothing happens was developed using mostly a statistical argument • Now incorporated into ASAPprime® • Handling secondary degradation complex but possible with accelerated aging • Only critical to deconvolute two rate constants when activation parameters (Ea, B) differ significantly • With enough data, can accurately model behavior across storage condition Key Words: Conditions, Shelf, Confidence

Best Practices • Best Practices • Data Analysis • Determination • Shelf-Life • Statistical • Statistics