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

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Error Bars for Predicted Shelf-LifeExample: Confidence IntervalFor 2 year shelf life (25ºC/60%RH) = 95%For 3 year shelf life (25ºC/60%RH) = 75%ln k70/75%RH80/4060/4050/75Ln A70/ 525ºC/60%RHB1/TE a /RCalculated using Monte-Carlo simulation process18
Error Bars for Predicted Shelf-Lifeln kExample: Confidence IntervalFor 2 year shelf life (25ºC/60%RH) = 99%For 3 year shelf life (25ºC/60%RH) = 95%70/75%RH80/4060/4050/7540/75Ln A70/ 525ºC/60%RHB1/TE a /R19
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 and 8: Stability at Different Temperatures
Page 9 and 10: 80CArrhenius Plot:Two Approaches70C
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: 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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