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

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Protocol ExampleFinal protocol may require several iterations!T (C) %RH Days(screeningprotocol)%Degradantusingscreening(generic)protocol50 75 14 0.45 760 40 14 0.24 14Days: Productspecificprotocol70 5 14 0.09 Not tested70 75 1 0.68 Not tested80 40 2 0.59 140 75 Not tested --- 2180 5 Not tested --- 1122
Protocol ExampleFinal protocol may require several iterations!T (C) %RH Days: Protocol 2(productspecific)%Degradant usingproduct specificprotocol40 75 21 0.230.0250 75 7 0.200.0260 40 14 0.220.0280 40 1 0.310.0280 5 11 0.180.0225C/60%RH shelf-life (PVC blister)25C/60%RH shelf-life (HDPE bottle)30C/65%RH shelf-life (HDPE bottle)30C/65%RH shelf-life (HDPE bottle, desiccant)2.9-6.0 yrs5.4-9.4 yrs2.3-3.4 yrs4.3-6.0 yrs23
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: 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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