1. Waterman R, Lewis J, Waterman KC.

Accelerated Stability Modeling for Peptides:

a Case Study with Bacitracin. AAPS PharmSciTech. 2016 Oct 6. PubMed PMID:
27714699.
https://www.ncbi.nlm.nih.gov/pubmed/27714699
2. Waterman KC, Chen L, Waterman P, MacDonald BC, Monahan AP, Scrivens G.
Modeling of in-use stability for tablets and powders in bottles. Drug Dev Ind
Pharm. 2016 Oct;42(10):1571-8. doi: 10.3109/03639045.2016.1153648. Epub
2016 Apr
PubMed PMID: 27050806.
https://www.ncbi.nlm.nih.gov/pubmed/27050806
3. Clancy D, Hodnett N, Orr R, Owen M, Peterson J. Kinetic Model Development for
Accelerated Stability Studies. AAPS PharmSciTech. 2016 Jul 15. [Epub ahead of
print] PubMed PMID: 27422651.
https://www.ncbi.nlm.nih.gov/pubmed/27422651
4. Navernik K, Jurei R. Humidity-corrected Arrhenius equation: The reference
condition approach. Int J Pharm. 2016 Mar 16;500(1-2):360-5. doi:
10.1016/j.ijpharm.2016.01.047. Epub 2016 Jan 21. PubMed PMID: 26802498.
https://www.ncbi.nlm.nih.gov/pubmed/26802498
5. Nurzyska K, Booth J, Roberts CJ, McCabe J, Dryden I, Fischer PM. Long-Term
Amorphous Drug Stability Predictions Using Easily Calculated, Predicted, and
Measured Parameters. Mol Pharm. 2015 Sep 8;12(9):3389-98.
doi:10.1021/acs.molpharmaceut.5b00409. Epub 2015 Aug 12. PubMed PMID:
26236939.
https://www.ncbi.nlm.nih.gov/pubmed/26236939
6. Fu M, Perlman M, Lu Q, Varga C. Pharmaceutical solid-state kinetic stability
investigation by using moisture-modified Arrhenius equation and JMP statistical
software. J Pharm Biomed Anal. 2015 Mar 25;107:370-7. doi:
10.1016/j.jpba.2015.01.014. Epub 2015 Jan 13. PubMed PMID: 25656488.
https://www.ncbi.nlm.nih.gov/pubmed/25656488
7. Fan Z, Zhang L. One- and two-stage Arrhenius models for pharmaceutical shelf
life prediction. J Biopharm Stat. 2015;25(2):307-16.
doi:10.1080/10543406.2014.972743. PubMed PMID: 25358076.
https://www.ncbi.nlm.nih.gov/pubmed/25358076
8. Clnet D, Imbert F, Probeck P, Rahman N, Ausar SF. Advanced kinetic analysis as
a tool for formulation development and prediction of vaccine stability. J Pharm
Sci. 2014 Oct;103(10):3055-64. doi: 10.1002/jps.24117. Epub 2014 Aug 19.
PubMed PMID: 25139388.
https://www.ncbi.nlm.nih.gov/pubmed/25139388
9. Waterman KC, Swanson JT, Lippold BL. A scientific and statistical analysis of
accelerated aging for pharmaceuticals. Part 1: accuracy of fitting methods. J
Pharm Sci. 2014 Oct;103(10):3000-6. doi: 10.1002/jps.24075. Epub 2014 Jul 8.
PubMed PMID: 25043838.
https://www.ncbi.nlm.nih.gov/pubmed/25043838
10. Rauk AP, Guo K, Hu Y, Cahya S, Weiss WF 4th. Arrhenius time-scaled least
squares: a simple, robust approach to accelerated stability data analysis for
bioproducts. J Pharm Sci. 2014 Aug;103(8):2278-86. doi: 10.1002/jps.24063.

Epub 2014 Jun 26. PubMed PMID: 24974956.

https://www.ncbi.nlm.nih.gov/pubmed/24974956
11.
Colgan, S.T., Timpano, R.J., Roberts, M. et al. Opportunities for Lean
Stability Strategies.
J Pharm Innov (2014) 9: 259. doi:10.1007/s12247-014-9198-x
http://link.springer.com/article/10.1007/s12247-014-9198-x

12.
Li, Q.C., Cohen, K., Tougas, T. et al. Best Practices for Drug Substance
Stress and Stability Studies During Early-Stage Development Part IIConducting
Abbreviated Long-Term and Accelerated Stability Testing on the First Clinical
Drug Substance Batch to Confirm and Adjust the Drug Substance Retest
Period/Powder for Oral Solution Shelf Life J Pharm Innov (2013) 8: 56.
doi:10.1007/s12247-013-9147-0
http://link.springer.com/article/10.1007%2Fs12247-013-9147-0
13. Remmelgas J, Simonutti AL, Ronkvist A, Gradinarsky L, Lfgren A. A mechanistic
model for the prediction of in-use moisture uptake by packaged dosage forms.
Int J Pharm. 2013 Jan 30;441(1-2):316-22. doi:10.1016/j.ijpharm.2012.11.025.
Epub 2012 Nov 27. PubMed PMID: 23194882.
https://www.ncbi.nlm.nih.gov/pubmed/23194882
14.
Colgan, S.T., Watson, T.J., Whipple, R.D. et al. The Application of Scienceand Risk-Based Concepts to Drug Substance Stability Strategies J Pharm Innov
(2012) 7: 205. doi:10.1007/s12247-012-9135-9
http://link.springer.com/article/10.1007%2Fs12247-012-9135-9
15. Waterman KC. The application of the Accelerated Stability Assessment Program
(ASAP) to quality by design (QbD) for drug product stability. AAPS PharmSciTech.
2011 Sep;12(3):932-7. doi: 10.1208/s12249-011-9657-3. Epub 2011 Jul 12.
PubMed PMID: 21748541; PubMed Central PMCID: PMC3167263.
https://www.ncbi.nlm.nih.gov/pubmed/21748541
16. Waterman KC, MacDonald BC. Package selection for moisture protection for
solid, oral drug products. J Pharm Sci. 2010 Nov;99(11):4437-52.
doi:10.1002/jps.22161. Review. PubMed PMID: 20845442.
https://www.ncbi.nlm.nih.gov/pubmed/20845442
17. Naversnik K, Bohanec S. Predicting drug hydrolysis based on moisture uptake in
various packaging designs. Eur J Pharm Sci. 2008 Dec 18;35(5):447-56. doi:
10.1016/j.ejps.2008.09.007. Epub 2008 Oct 1. PubMed PMID: 18940251.
https://www.ncbi.nlm.nih.gov/pubmed/18940251
18. Oliva A, Llabrs M, Faria JB. Data analysis of kinetic modelling used in drug
stability studies: isothermal versus nonisothermal assays. Pharm Res. 2006
Nov;23(11):2595-602. Epub 2006 Sep 13. PubMed PMID: 16969699.
https://www.ncbi.nlm.nih.gov/pubmed/16969699

19. Chen Y, Li Y. A new model for predicting moisture uptake by packaged solid
pharmaceuticals. Int J Pharm. 2003 Apr 14;255(1-2):217-25. PubMed PMID:
12672617.
https://www.ncbi.nlm.nih.gov/pubmed/12672617
20. Some IT, Bogaerts P, Hanus R, Hanocq M, Dubois J. Stability parameter
estimation at ambient temperature from studies at elevated temperatures. J
Pharm Sci. 2001 Nov;90(11):1759-66. PubMed PMID: 11745733.
https://www.ncbi.nlm.nih.gov/pubmed/11745733
21. Badawy SI, Gawronski AJ, Alvarez FJ. Application of sorptiondesorption
moisture transfer modeling to the study of chemical stability of a moisture
sensitive drug product in different packaging configurations. Int J Pharm. 2001
Jul 31;223(1-2):1-13. PubMed PMID: 11451627.
https://www.ncbi.nlm.nih.gov/pubmed/11451627
22. Allinson JG, Dansereau RJ, Sakr A. The effects of packaging on the stability of a
moisture sensitive compound. Int J Pharm. 2001 Jun 19;221(1-2):49-56. PubMed
PMID: 11397566.
https://www.ncbi.nlm.nih.gov/pubmed/11397566
23. King SY, Kung MS, Fung HL. Statistical prediction of drug stability based on
nonlinear parameter estimation. J Pharm Sci. 1984 May;73(5):657-62. PubMed
PMID: 6737241.
https://www.ncbi.nlm.nih.gov/pubmed/6737241

Yang, H. & Zhang, L. 2012, "Evaluation of Statistical Methods for Estimating

Shelf Life of Drug Products: A Unified and Risk-Based Approach", Journal of
Validation Technology, vol. 18, no. 2, pp. 67-74.
Porter, W.R. 2012, "Thermally Accelerated Degradation and Storage
Temperature Design Space for Liquid Products", Journal of Validation
Technology, vol. 18, no. 3, pp. 73-92.
Little, T.A., PhD. 2014, "Accelerated Stability Modeling", Biopharm International,
vol. 27, no. 5, pp. 40-43.
Magari, R.T. 2003, "Assessing shelf life using real-time and accelerated stability
tests", Biopharm International, vol. 16, no. 11, pp. 36-40,42,44,46,48.
Alasandro, M. & Little, T.A. 2014, "Multifactor Non-linear Modeling for
Accelerated Stability Analysis and Prediction", Pharmaceutical Technology, vol.
38, no. 7, pp. 46-49.