Stability - ASAPprime
The ASAPprime software is the only commercially-available software that enables pharmaceutical scientists to quickly and accurately determine drug substance and drug product shelf-life based on the Accelerated Stability Assessment Program (ASAP). This state-of-the-art, statistical software allows prediction of small-molecule drug product use periods, shelf-lives and drug substance retest periods in as little as two weeks based on the methods popularized by the company founder.
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FASTER SHELF-LIFE DETERMINATION
- FASTER SHELF-LIFE DETERMINATION
- 2-4 weeks vs. ICH-based standard of 2-6 months
- OPTIMAL PACKAGING SELECTION
- Eliminates screening
- Allows for zone packaging selection
- SUPPORT OF REGULATORY FILINGS
- Provides better insights into packaging and formulation/process choices
- Supports QbD filings
- Replaces or supplements ICH-based studies for FDA and other regulatory agencies world-wide
- STABILITY
- Accurately assess stability and shelf life variation between product lots
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