Accelerated Stability Assessment Program (ASAP) - American ...

Bridging Science and Regulations• Early Clinical Trials– Use ASAP to support Clinical Use Period assignments• During Development– Use ASAP to predict stability for changes in:• Formulations/processes• Synthetic routes• Packaging• At Registration– Use ASAP as supportive data or as an alternative to traditional stabilityto minimize stability commitments• Post-Approval– Use ASAP to justify changes that will not affect stability– Replace annual commitment with ASAP commitment37