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

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Stability at Different Temperatures:ASAP (Isoconversion) Approach0 100 200 300 400 500 600High TLow TASAP approach: % degradant fixed atspecification limit, time adjusted as needed8
80CArrhenius Plot:Two Approaches70C 60C 50C30CisoconversionCP-456,773/60%RHHistorical method: highT deviations give nonlinearbehaviorReal time dataPredicted Shelf Life (historical method)Predicted Shelf Life (ASAP/isoconversion)Experimental Shelf Life0.5 yrs1.2 yrs1.2 yrs9
Page 1 and 2: Accelerated Stability AssessmentPro
Page 3 and 4: Accelerated Stability AssessmentPro
Page 5 and 6: log kExcipient/API Interactions-0.6
Page 7: Stability at Different Temperatures
Page 11 and 12: Aspirin Tablet Degradation70C50C 40
Page 13 and 14: Effect of B Values on Shelf Life (C
Page 15 and 16: ASAP Screening-Protocol: Set to Gen
Page 17 and 18: Error Bars for Predicted Shelf-Life
Page 19 and 20: Error Bars for Predicted Shelf-Life
Page 21 and 22: Protocol ExampleFinal protocol may
Page 23 and 24: Protocol ExampleFinal protocol may
Page 25 and 26: Packaged-Product StabilityH 2 OH 2
Page 27 and 28: %H 2 OMoisture Sorption Isotherm—
Page 29 and 30: Moisture Vapor Transmission Rateper
Page 31 and 32: %RHEmpty Bottle/Blister Equilibrati
Page 33 and 34: %RHPredicted (Lines) vs. Measured R
Page 35 and 36: Example 2: More Stable Drug Product
Page 37 and 38: Bridging Science and Regulations•
Page 39 and 40: Acknowledgments• Pfizer scientist

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