Accelerated Stability Assessment Program (ASAP) - American ...
Accelerated Stability Assessment Program (ASAP) - American ... Accelerated Stability Assessment Program (ASAP) - American ...
Related Publications• Waterman, K.C.; MacDonald, B.C. Package selection for moisture protection for solid, oraldrug products, J. Pharm. Sci. 99 (2010) 4437-4452; (on line) DOI 10.1002/jps.22161 (2010)• Waterman, K.C. Accelerated stability assessment program (ASAP): using science to set shelflife, accepted in American Pharm. Rev.• Waterman, K.C. Understanding and predicting pharmaceutical product shelf-life. In Handbookof Stability Testing in Pharmaceutical Development: Regulations, Methodologies and BestPractices, Huynhba, K., Ed. Springer Science and Media Publishing, Chapter 6 (2008) 115-135.• Waterman, K.C.; Colgan, S.T. A science-based approach to setting expiry dating for solid drugproducts. Regulatory Rapporteur 5 (2008) 9-14.• Waterman, K.C.; Carella, A.J.; Gumkowski, M.J.; Lukulay, P.; MacDonald, B.C.; Roy, M.C.;Shamblin, S.L. Improved protocol and data analysis for accelerated shelf-life estimation ofsolid dosage forms. Pharmaceutical Research 24 (2007) 780-790.• Waterman, K.C.; Adami, R.C. Accelerated aging: prediction of chemical stability ofpharmaceuticals. Intern. J. Pharm. 293 (2005) 101-125.• Waterman, K.C.; Adami, R.C., Hong, J. Impurities in drug products. In Handbook of Isolationand Characterization of Impurities in Pharmaceuticals. S. Ajira and K.M. Alsante, Eds. 2003,pp. 75-85.• Waterman, K.C.; Adami, R.C.; Alsante, K.M.; Antipas, A.S.; Arenson, D.R.; Carrier, R.; Hong,J.; Landis, M.S.; Lombardo, F.; Shah, J.C.; Shalaev, E.Y.; Smith, S.W.; Wang, H. Hydrolysis inpharmaceutical formulations. Pharm. Dev. Tech. 7 (2002) 113-146.• Waterman, K.C.; Adami, R.C.; Alsante, K.M.; Hong, J.; Landis, M.S.; Lombardo, F.; Roberts,C.J. Stabilization of pharmaceuticals to oxidative degradation. Pharm. Dev. Tech. 7 (2002) 1-32.40
- 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 and 38: Bridging Science and Regulations•
- Page 39: Acknowledgments• Pfizer scientist
Related Publications• Waterman, K.C.; MacDonald, B.C. Package selection for moisture protection for solid, oraldrug products, J. Pharm. Sci. 99 (2010) 4437-4452; (on line) DOI 10.1002/jps.22161 (2010)• Waterman, K.C. <strong>Accelerated</strong> stability assessment program (<strong>ASAP</strong>): using science to set shelflife, accepted in <strong>American</strong> Pharm. Rev.• Waterman, K.C. Understanding and predicting pharmaceutical product shelf-life. In Handbookof <strong>Stability</strong> Testing in Pharmaceutical Development: Regulations, Methodologies and BestPractices, Huynhba, K., Ed. Springer Science and Media Publishing, Chapter 6 (2008) 115-135.• Waterman, K.C.; Colgan, S.T. A science-based approach to setting expiry dating for solid drugproducts. Regulatory Rapporteur 5 (2008) 9-14.• Waterman, K.C.; Carella, A.J.; Gumkowski, M.J.; Lukulay, P.; MacDonald, B.C.; Roy, M.C.;Shamblin, S.L. Improved protocol and data analysis for accelerated shelf-life estimation ofsolid dosage forms. Pharmaceutical Research 24 (2007) 780-790.• Waterman, K.C.; Adami, R.C. <strong>Accelerated</strong> aging: prediction of chemical stability ofpharmaceuticals. Intern. J. Pharm. 293 (2005) 101-125.• Waterman, K.C.; Adami, R.C., Hong, J. Impurities in drug products. In Handbook of Isolationand Characterization of Impurities in Pharmaceuticals. S. Ajira and K.M. Alsante, Eds. 2003,pp. 75-85.• Waterman, K.C.; Adami, R.C.; Alsante, K.M.; Antipas, A.S.; Arenson, D.R.; Carrier, R.; Hong,J.; Landis, M.S.; Lombardo, F.; Shah, J.C.; Shalaev, E.Y.; Smith, S.W.; Wang, H. Hydrolysis inpharmaceutical formulations. Pharm. Dev. Tech. 7 (2002) 113-146.• Waterman, K.C.; Adami, R.C.; Alsante, K.M.; Hong, J.; Landis, M.S.; Lombardo, F.; Roberts,C.J. Stabilization of pharmaceuticals to oxidative degradation. Pharm. Dev. Tech. 7 (2002) 1-32.40
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