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Accelerated Stability Assessment Program (ASAP) - Fast Determination of Drug Product Shelf-Life

Speaker:

Ken Waterman (President and Founder , Free Think Technologies, Inc.)

Location: 119A

Date: Wednesday, April 25

Time: 2:30pm - 3:15pm

Pass Type: Conference Pass, VIP Attendee - Get your pass now!

Track: Drug Development

Vault Recording: TBD

The Accelerated Stability Assessment Program, ASAP, is a revolutionary process that allows companies to determine drug product shelf-life in just three weeks. The combination of studies and mathematical/statistical analysis (using the ASAPprime® software) has been successfully used by many pharmaceutical companies for numerous drug products to speed product development, including formulation selection, process development and packaging selection. Moreover, ASAP has been used in many regulatory filings from clinical studies to registration (NDA and ANDA filings) and post-approval changes.

ASAP uses designed temperature/RH conditions (open) to build a validated mathematical model for stability based on pushing the product to its failure point at each condition. The packaging is calculated based on product needs for protection from moisture and oxygen.

Presentation File

5.pptx