Accelerated Stability Assessment Program (ASAP) - American ...
Accelerated Stability Assessment Program (ASAP) - American ...
Accelerated Stability Assessment Program (ASAP) - American ...
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<strong>Accelerated</strong> <strong>Stability</strong> <strong>Assessment</strong><strong>Program</strong> (<strong>ASAP</strong>)• Modeling tool that improves product understanding• Credible predictions for product expiration dating– Reduces uncertainty– Has the potential to change the way industry meets its stabilitycommitments• Clinical investigations• Registration• Annual review• Post-Approval Changes• Scope– Solid drug products– Solid API’s– Small molecules3
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