Accelerated Stability Assessment Program (ASAP) - American ...
Accelerated Stability Assessment Program (ASAP) - American ... Accelerated Stability Assessment Program (ASAP) - American ...
from mediaserver.aaps.org
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12.07.2015
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Conclusions• ASAP provides a scientific basis for setting shelf-lives– Dramatically shorter time– Better understanding– Lower risk• Allows package selection without screening—lowersrisk + saves time38
Acknowledgments• Pfizer scientists Groton and Sandwich• Paul Gerst• Bruce MacDonald• Mike Roy• Anthony Carella• Garry Scrivens39
- 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 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: Bridging Science and Regulations•
Conclusions• <strong>ASAP</strong> provides a scientific basis for setting shelf-lives– Dramatically shorter time– Better understanding– Lower risk• Allows package selection without screening—lowersrisk + saves time38
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