FreeThink Technologies Inc.

Stability -Ā ASAPprime

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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
    • 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