Development, Comparison, and Qualification of Predictive Pharmaceutical Stability Models Using Independent Statistical Tools

McMahon M, Williams H, Debie E, Fu M, Bujalski R, et al. Utilization of risk-based Predictive Stability within Regulatory submissions: Industry’s experience. AAPS Open. 2020;6:1.

Article  Google Scholar 

Qiu F, Scrivens G. Accelerate Predictive Stability (APS): fundamentals and Pharmaceutical Industry practices. Cambridge, MA: Academic; 2018.

Google Scholar 

Williams H, Stephens D, McMahon M, Debie E, Qiu F, Hyzer CH, Sechler L, Orr R, Webb D, Wu Y, Hahan D. Risk-based Predictive Stability – An Industry Perspective. Pharm Tech. 2017;41(3):52–7.

Google Scholar 

Bajaj S, Singla D, Sakhuja N. Stability Testing of Pharmaceutical products. J App Pharm Sci. 2012;02(03):129–38.

Google Scholar 

McMahon M, Abbott A, Babayan Y, Carhart J, Chen C, Debie E, Fu M, et al. Considerations for updates to ICH Q1 and Q5C Stability guidelines: Embracing Current Technology and Risk Assessment Strategies. AAPS J. 2021;23:107.

Article  PubMed  Google Scholar 

Gonzalez O, Ramirez IO, Ramirez BI, OConnell P, Ballesteros MP, Torradol JJ, Serrano DR. Drug stability: ICH versus accelerated predictive stability studies. Pharmaceutics. 2022;14(11):2324.

Article  Google Scholar 

Nelson P. Stability Prediction using the Arrhenius Model. Comput Methods Programs Biomed. 1983;16(1):55–60.

Article  CAS  Google Scholar 

Roy S, Siddique S, Majumder S, Abdul M, Rahman S, Lateef D, Dan S, Bose A. A systemic Approach on understanding the role of moisture in Pharmaceutical Product Degradation and its Prevention: challenges and Perspective. Biomed Res. 2018;29(17):3336–43.

Article  CAS  Google Scholar 

Ofner C, Zhang Y, Jobeck V, Bowman B. Crosslinking studies in gelatin capsules treated with Formaldehyde and in Capsules exposed to elevated temperature and humidity. J Pharm Sci. 2001;90(1):79–88.

Article  CAS  PubMed  Google Scholar 

Waterman K, Adami R, Accelerated, Aging. Prediction of Chemical Stability of Pharmaceuticals. Int J Pharm. 2005;293(1–2):101–25.

Article  CAS  PubMed  Google Scholar 

Genton D, Kesselring U. Effect of temperature and relative humidity on Nitrazepam Stabiliyt in Solid State. J Pharm Sci. 1977;66(5):676–80.

Article  CAS  PubMed  Google Scholar 

Waterman K. The application of the Accelerated Stability Assessment Program (ASAP) to quality by design (QbD) for Drug Product Stability. AAPS PharmSciTech. 2011;12(3):932–7.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Waterman K, Carella A, Gumkowski M, Lukulay P, MaDonald B, Roy M, Shamblin S. Improved Protocol and Data Analysis for Accelerated Shelf-life estimation of solid dosage form. Pharm Res. 2007;24(4):780–90.

Article  CAS  PubMed  Google Scholar 

Waterman K, Swanson J, Lippold B. A scientific and Statistical Analysis of Accelerated Aging for Pharmaceuticals. Part 1: accuracy of fitting methods. J Pharm Sci. 2014;103(10):3000–6.

Article  CAS  PubMed  Google Scholar 

Weiss WF, Young TM, Roberts CJ. Principles, approaches, and challenges for Predicting Protein Aggregation Rates and Shelf Life. J Pharm Sci. 2009;98(4):1246–77.

Article  CAS  PubMed  Google Scholar 

Wulandari L, Idroes R, Noviandy T, et al. Chapter six – application of Chemometrics using direct spectroscopic methods as a QC Toool in Pharmaceutical Industry and their validation. Profiles Drug Subst Excip Relat Methodol. 2022;47:327–79.

Article  CAS  PubMed  Google Scholar 

Gumieniczek A, Berecka-Rycerz A, Trebacz H, Barzycka A, Leyk E, Wesolowski M, DSC. FT-IR and NIR with Chemometric Assessment Using PCA and HCA for estimation of the Chemical Stability of oral antidiabetic drug Linagliptin in the Presence of Pharmaceutical excipients. Molecules. 2022;27(13):4283.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Some I, Bogaerts P, Hanus R, Hanocq M, Dubois J. Incorporating batch effects in the estimation of Drug Stabilty parameters using an Arrhenius Model. Int J Pharm. 1999;184(2):165–72.

Article  CAS  PubMed  Google Scholar 

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;107:370–7.

Article  CAS  PubMed  Google Scholar 

Zhang J, Ying Y, Pielecha-Safira B, Bilgili E, et al. Raman Spectroscopy for In-line and off-line quantification of poorly soluble drugs in Strip films. Int J Pharm. 2014;475(1–2):428–37.

Article  CAS  PubMed  Google Scholar 

Zomer S, Zhang J, Talwar S, Chattoraj S, Hewitt C. Multivariate monitoring for the Industrialisation of a continuous wet granulation tableting process. Int J Pharm. 2018;547(1–2):506–19.

Article  CAS  PubMed  Google Scholar 

Wu S, Panikar S, Singh R, Zhang J, Glasser B, Ramachandran R. A systematic framework to monitor mulling processes using Near Infrared spectroscopy. Adv Powder Technol. 2016;27(4):1115–27.

Article  Google Scholar 

Greenspan L. Humidity fixed points of Binary Saturated Aqueous solutions. J Res Natl Bur Stand. 1977;81(1):89–96.

Article  Google Scholar 

International Conference on Harmonization of Technical Requirements. for Registration of Pharmaceuticals for Human Use ICH Q1A(R2) Stability Test of New Drug Substances and Products. https://www.ich.org/page/ich-guidelines.

International Conference on Harmonization of Technical Requirements. for Registration of Pharmaceuticals for Human Use ICH Q3A(R2) Impurities In New Drug Substances. https://www.ich.org/page/ich-guidelines.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH M7(R1.) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. https://www.ich.org/page/ich-guidelines.

Waterman K. Understanding and Predicting Pharmaceutical Product Shelf-life, Handbook of Stability Testing in Pharmaceutical Development: regulations, methodologies and Best practices. New York: Springer Science and Media Publishing; 2008. pp. 115–35.

Google Scholar 

Ahuja S, Scypinski S. Handbook of Modern Pharmaceutical Analysis. Acad Press. 2011;10:71–3. Separation Science and Technology2nd ed.

Google Scholar 

Waterman K, MacDonald B. Package Selection for Moisture Protection for solid oral drug products. J Pharm Sci. 2010;99(11):4437–51.

Article  CAS  PubMed  Google Scholar 

Wynne WC. How to write up and report PLS analysis. In: Esposito Vinzi V, Chin WW, Henseler J, Wang H, editors. Handbook of partial least squares: concepts, methods and application. Heidelberg, Dordrecht, London, New York: Springer; 2010. pp. 655–90. https://doi.org/10.1007/978-3-540-32827-8_29.

Chapter  Google Scholar 

Allinson J, Dansereau R, Sakr A. The effects of Packaging on the Stability of a moisture sensitive compound. Int J Pharm. 2001;221(1–2):49–56.

Article  CAS  PubMed  Google Scholar 

Comments (0)

No login
gif