Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Ich harmonised tripartite guideline, stability testing of new drug substances and products q1a (R2). 2003. https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf. Accessed 2 Oct 2023.

Waterman KC, Adami R. Accelerated aging: prediction of chemical stability of pharmaceuticals. Int J Pharm. 2005;293(1–2):101–25.

Article  CAS  PubMed  Google Scholar 

Waterman KC, Carella AJ, Gumkowski MJ, Lukulay P, MacDonald BC, Roy MC, et al. Improved protocol and data analysis for accelerated shelf-life estimation of solid dosage forms. Pharm Res. 2007;24(4):780–90.

Article  CAS  PubMed  Google Scholar 

Oliva A, Faria JB, Llabrés M. An improved methodology for data analysis in accelerated stability studies of peptide drugs: practical considerations. Talanta. 2012;94:158–66.

Article  CAS  PubMed  Google Scholar 

Clancy D, Hodnett N, Orr R, Owen M, Peterson J. Kinetic model development for accelerated stability studies. AAPS PharmSciTech. 2017;18(4):1158–76. https://doi.org/10.1208/s12249-016-0565-4.

Article  CAS  PubMed  Google Scholar 

Williams H, Bright J, Roddy E, Poulton A, Cosgrove SD, Turner F, et al. A comparison of drug substance predicted chemical stability with ICH compliant stability studies. Drug Develop Ind Pharm. 2018;45(3):379–86.

Article  Google Scholar 

Furness MS, Cai H, Chandramouli S, Chelliah M, Chen XH, Ghosh D, et al. modeling approaches to reimagine stability (MARS) for enabling earlier access to critical drugs for patients with unmet medical needs. AAPS PharmSciTech. 2023;24:35. https://doi.org/10.1208/s12249-022-02498-0.

Article  PubMed  Google Scholar 

Williams H, Stephens D, McMahon M, Debie E, Qiu F, Hyzer CH, et al. Risk based predictive stability - an industry perspective. Pharmaceutical Technology. 2017;41(3):52–7. https://www.pharmtech.com/view/risk-based-predictive-stability-industry-perspective. Accessed 2 Oct 2023. 

Stephens D, Williams H, McMahon M, Qiu F, Hyzer CH, Debie E, et al. Risk-based predictive stability for pharmaceutical development–a proposed regulatory template. Pharmaceutical Technology. 2018;42(8):42–47. https://www.pharmtech.com/view/risk-based-predictive-stability-pharmaceutical-development-proposed-regulatory-template. Accessed 2 Oct 2023.

McMahon M, Williams H, Debie E, Fu M, Bujalski R, Qiu F, et al. Utilization of risk-based predictive stability within regulatory submissions; industry’s experience. AAPS Open. 2020;6:1. https://doi.org/10.1186/s41120-020-00034-7.

Article  Google Scholar 

McMahon M, Abbott A, Babayan Y, Carhart J, Chen C, Debie E, et al. Considerations for updates to ICH Q1 and Q5C stability guidelines: embracing current technology and risk assessment strategies. AAPS J. 2021;23:10. https://doi.org/10.1208/s12248-021-00641-610.1208/s12249-011-9657-3.

Article  Google Scholar 

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Ich harmonised tripartite guideline, pharmaceutical development q8(R2). 2009. https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.pdf. Accessed 2 Oct 2023.

International council for harmonisation of technical requirements for pharmaceuticals for human use, ich harmonised guideline. Quality risk management q9(R1). 2023. https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2023_0126_0.pdf. Accessed 2 Oct 2023.

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised Tripartite Guideline, Pharmaceutical Quality System Q10. 2008. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf. Accessed 2 Oct 2023.

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised Tripartite Guideline, development and manufacture of drug substances (chemical entities and biotechnological/biological entities) Q11. 2012. https://database.ich.org/sites/default/files/Q11%20Guideline.pdf. Accessed 2 Oct 2023.

International council for harmonisation of technical requirements for pharmaceuticals for human use. ICH Harmonised Guideline, Technical and regulatory considerations for pharmaceutical product lifecycle management Q12. 2019.  https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf. Accessed 2 Oct 2023.

Beierle J, Cauchon NS, Graul T, Hedberg Y, Holm M B, Lepore JV, et al. Toward a single global control strategy: industry study. Pharmaceutical Engineering. 2022. https://ispe.org/pharmaceutical-engineering/january-february-2022/toward-single-global-control-strategy-industry#. Accessed 2 Oct 2023.

Control of Nitrosamine Impurities in Human Drugs, Guidance for Industry, U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), February 2021. Pharmaceutical Quality/ Manufacturing Standards/ Current Good Manufacturing Practice (CGMP) Revision 1. https://www.fda.gov/media/141720/downloadhttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs. Accessed 2 Oct 2023.

Waterman KC. The application of the accelerated stability assessment program (ASAP) to quality by design (QbD) for drug product stability. AAPS PharmSciTech. 2011;12:932–7. https://doi.org/10.1208/s12249-011-9657-3.

Article  CAS  PubMed  PubMed Central  Google Scholar 

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised Tripartite Guideline, EVALUATION FOR STABILITY DATA Q1E. 2003.  http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1E/Step4/Q1E_Guideline.pdf. Accessed 2 Oct 2023.

Skrdla PJ, Wang T, Antonucci V. Use of a quality-by-design approach to justify removal of the HPLC weight % assay from routine API stability testing protocols. J Pharm Biomed Anal. 2009;50(5):794–6.

Article  CAS  PubMed  Google Scholar 

European Medicines Agency Inspections, Committee for medicinal products for human use (chmp), guideline on the pharmaceutical quality of inhalation and nasal products. Doc Ref.: EMEA/CHMP/QWP/49313/2005 Corr. 2006. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-quality-inhalation-nasal-products_en.pdf. Accessed 2 Oct 2023.

Guidance for Industry, Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing, and Controls Documentation, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). 2002. https://www.fda.gov/media/70857/download. Accessed 2 Oct 2023.

Norwood DL, Paskiet D, Ruberto M, Feinberg T, Schroeder A, Poochikian G, et al. Best practices for extractables and leachables in orally inhaled and nasal drug products: an overview of the PQRI recommendations. Pharm Res. 2008;25(4):727–39. https://doi.org/10.1007/s11095-007-9521-z.

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised Tripartite Guideline, Bracketing and matrixing designs for stability testing of new drug substances and products Q1D. 2002. https://database.ich.org/sites/default/files/Q1D%20Guideline.pdf. Accessed 2 Oct 2023.

Comparability protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA, Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation (CBER), Pharmaceutical Quality/CMC. 2022. https://www.fda.gov/media/162263/download. Accessed 17 Oct 2022.

International consortium for innovation & quality in Pharmaceutical Development, Science & Risk Based Stability Practices in Pharmaceutical Development Webinar Series, Part I (February 3, 2022): Application of Science and Risk-based Predictive Stability to Small Molecule Therapeutics (Regler B, Hertzler R); Part II (February 10, 2022): Application of Science & Risk Based Predictive Stability to Biological Therapeutics (McCaig L, Lennard A, Woodlief K, Willingmyre D); Part III (February 17, 2022): Leveraging Available Knowledge to Design Appropriate Studies (Pellett J, Gerst P); and Part IV (February 24, 2022): Regulatory Landscape of Science & Risk Based Stability (Wu Y, McMahon M, Babayan Y).

Huelsmeyer M, Kuzman D, Bončina M, Martinez J, Steinbrugger C, Weusten J, et al. A universal tool for stability predictions of biotherapeutics, vaccines and in vitro diagnostic products. Sci Rep. 2023;13:10077.

Article  ADS  CAS  PubMed  PubMed Central  Google Scholar 

Campa C, Pronce T, Paludi M, Weusten J, Conway L, Savery J, et al. use of stability modeling to support accelerated vaccine development and supply. Vaccines. 2021;9(10):1114.

Article  PubMed  PubMed Central  Google Scholar 

Evers A, Clénet D, Pfeiffer-Marek S. Long-term stability prediction for developability assessment of biopharmaceutics using advanced kinetic modelling. Pharmaceutics. 2022;14:375.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Neyra C, Clénet D, Bright M, Kensinger R, Hauser S. Predictive modeling for assessing the long-term thermal stability of a new fully-liquid quadrivalent meningococcal tetanus toxoid conjugated vaccine. Int J Pharm. 2021;609: 121143.

Article  CAS  PubMed  Google Scholar 

Roduit B, Luyet CA, Hartmann M, Folly P, Sarbach A, Dejeaifve A, et al. Continuous monitoring of shelf lives of materials by application of data loggers with implemented kinetic parameters. Molecules. 2019;24:2217–42.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Clénet D. Accurate prediction of vaccine stability under real storage conditions and during temperature excursions. Eur J Pharm Biopharm. 2018;125:76–84.

Article  PubMed  Google Scholar 

Clenet 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;103:3055–64.

Article  CAS  PubMed  Google Scholar 

留言 (0)

沒有登入
gif