Εμφανίζονται 1 - 20 Αποτελέσματα από 53 για την αναζήτηση '"ФОТОСТАБИЛЬНОСТЬ"', χρόνος αναζήτησης: 0,66δλ Περιορισμός αποτελεσμάτων
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    Academic Journal

    Συνεισφορές: This study was conducted by the Scientific Centre for Expert Evaluation of Medicinal Products as part of the applied research funded under State Assignment No. 056-00026-24-01 (R&D Registry No. 124022200103-5), Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00026-24-01 на проведение прикладных научных исследований (номер государственного учета НИР № 124022200103-5)

    Πηγή: Biological Products. Prevention, Diagnosis, Treatment; Том 24, № 3 (2024); 335-347 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 24, № 3 (2024); 335-347 ; 2619-1156 ; 2221-996X ; 10.30895/2221-996X-2024-24-3

    Περιγραφή αρχείου: application/pdf

    Relation: https://www.biopreparations.ru/jour/article/view/613/918; https://www.biopreparations.ru/jour/article/downloadSuppFile/613/1039; Berkowitz S, Rathore AS, Krull IS. Challenges in the determination of protein aggregates. Part II. LCGC North Am. 2015;33(7):478–89.; Rathore AS, Krull IS. Challenges in the determina tion of protein aggregates. Part I. LCGC North Am. 2015;33(1):42–9.; Noel JC, Lagassé D, Golding B, Sauna ZE. Emerging approaches to induce immune tolerance to therapeutic proteins. Trends Pharmacol Sci. 2023;44(12):1028–42. https://doi.org/10.1016/j.tips.2023.10.002; Wearne SJ, Creighton TE. Effect of protein conformation on rate of deamidation: ribonuclease A. Proteins. 1989;5(1):8–12. https://doi.org/10.1002/prot.340050103; Grigolato F, Arosio P. Synergistic effects of flow and interfaces on antibody aggregation. Biotechnol Bioeng. 2020;117(2):417–28. https://doi.org/10.1002/bit.27212; Shah M. Commentary: New perspectives on protein aggregation during biopharmaceutical development. Int J Pharm. 2018;552(1–2):1–6. https://doi.org/10.1016/j.ijpharm.2018.09.049; Chi EY, Krishnam S, Randolph TW, Carpenter JF. Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation. Pharm Res. 2003;20(9):1325–36. https://doi.org/10.1023/a:1025771421906; Jacob S, Shirwaikar AA, Srinivasan KK, Alex J, Prabu SL, Mahalaxmi R, Kumar R. Stability of proteins in aqueous solution and solid state. Indian J Pharm Sci. 2006;68(2):154–63. https://doi.org/10.4103/0250-474X.25708; Larson NR, Wei Y, Prajapati I, Chakraborty A, Peters B, Kalonia C, et al. Comparison of polysorbate 80 hydrolysis and oxidation on the aggregation of a monoclonal antibody. J Pharm Sci. 2020;109(1):633–9. https://doi.org/10.1016/j.xphs.2019.10.069; Xie M, Schowen R. Secondary structure and protein deamidation. J Pharm Sci. 1999;88(1):8–13. https://doi.org/10.1021/js9802493; Cohen S, Price C, Vlasak J. β-Elimination and peptide bond hydrolysis: two distinct mechanisms of human IgG1 hinge fragmentation upon storage. J Am Chem Soc. 2007;129(22):6976–7. https://doi.org/10.1021/ja0705994; Cordoba AJ, Shyong B, Breen D, Harris RJ. Non-enzy matic hinge region fragmentation of antibodies in solution. J Chromatogr B Analyt Technol Biomed Life Sci. 2005;818(2):115–21. https://doi.org/10.1016/j.jchromb.2004.12.033; Werner R, Kopp K, Schlueter M. Glycosylation of therapeutic proteins in different production systems. Acta Paediatr. 2007;96(455):17–22. https://doi.org/10.1111/j.1651-2227.2007.00199.x; Luo D, Smith SW, Anderson BD. Kinetics and mechanism of the reaction of cysteine and hydrogen peroxide in aqueous solution. J Pham Sci. 2005;94(2):304–16. https://doi.org/10.1002/jps.20253; Cleland JL, Lam X, Kendrick B, Yang J, Yang T, Overca shier D, et al. A specific molar ratio of stabilizer to protein is required for storage stability of a lyophilized monoclonal antibody. J Pharm Sci. 2001;90(3):310–21. https://doi.org/10.1002/1520-6017(200103)90:3%3C310::aid-jps6%3E3.0.co;2-r; Constantino HR, Carrasquillo KG, Cordero RA, Mumenthaler M, Hsu CC, Gribenow K. Effect of excipients on the stability and structure of lyophilized recombinant human growth hormone. J Pharm Sci. 1998;87(11):1412–20. https://doi.org/10.1021/js980069t; Lai MC, Topp EM. Solid-state chemical stability of proteins and peptides. J Pharm Sci. 1999;88(5):489–500. https://doi.org/10.1021/js980374e; Li S, Patapoff TW, Overcashier, D, Hsu C, Nguyen TH, Borchardt RT. Effects of reducing sugars on the chemical stability of human relaxin in the lyophilized state. J Pharm Sci. 1996;85(8):873–7. https://doi.org/10.1021/js950456s; Narhi LO, Chou DK, Christian TR, Gibson S, Jaganna than B, Jiskoot W, et al. Stress factors in primary packaging, transportation and handling of protein drug prod ucts and their impact on product quality. J Pharm Sci. 2022;111(4):887–902. https://doi.org/10.1016/j.xphs.2022.01.011; Besheer A, Burton L, Galas RJ Jr, Gokhale K, Goldbach P, Hu Q, et al. An industry perspective on compatibility assessment of closed system drug-transfer devices for bio logics. J Pharm Sci. 2021;110(2):610–4. https://doi.org/10.1016/j.xphs.2020.10.047; Campa C, Pronce T, Paludi M, Weusten J, Conway L, Savery J, et al. Use of stability modeling to support acceler ated vaccine development and supply. Vaccines (Basel). 2021;9(10):1114. https://doi.org/10.3390/vaccines9101114; Bunc M, Hadži S, Graf C, Bončina M, Lah J. Aggregation time machine: a platform for the prediction and optimization of long-term antibody stability using short-term kinetic analysis. J Med Chem. 2022;65(3):2623–32. https://doi.org/10.1021/acs.jmedchem.1c02010; https://www.biopreparations.ru/jour/article/view/613

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    Academic Journal

    Συνεισφορές: This work did not have funding from outside organizations, Данная работа не имела финансирования от сторонних организаций

    Πηγή: Pharmacy & Pharmacology; Том 8, № 4 (2020); 242-254 ; Фармация и фармакология; Том 8, № 4 (2020); 242-254 ; 2413-2241 ; 2307-9266 ; 10.19163/2307-9266-2020-8-4

    Περιγραφή αρχείου: application/pdf

    Relation: https://www.pharmpharm.ru/jour/article/view/729/620; https://www.pharmpharm.ru/jour/article/view/729/624; Государственная Фармакопея Российской Федерации. Изд. XIV. Т. 1. – М., 2018. [Электронный ресурс]. http://feml.scsml.rssi.ru/feml; ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (Revision 2), International Conference on Harmonization; 2003. [Электронный ресурс]. – https://www.ema.europa.eu/en/documents/scientific–guideline/ich-q-1-r2-stability-testing-new-drugsubstances-products-step-5_en.pdf; ICH Guidance, Q1C: Stability Testing for New Drug Dosage Forms, International Conference on Harmonization. 1996. [Электронный ресурс]. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-c-stability-testingrequirements-new-dosage-forms-step-5_en.pdf; Existing Active Ingredients and Related Finished Products (CPMP/QWP/122/02 Rev. 1 corr), 2003. [Электронный ресурс]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003466.pdf; ICH Guidance, Q1B: Photostability Testing of New Drug Substances and Products, International Conference on Harmonization, 1998. [Электронный ресурс] https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-b-photostability-testing-new-active-substancesmedicinal-products-step-5_en.pdf; FDA Guidance for Industry, INDs for Phase II and III Studies – Chemistry, Manufacturing and Controls Information, Food and Drug Administration, 2003. [Электронный ресурс]. – https://www.fda.gov/media/70822/download; Klauda, J.B., Venable, R.M., Freites, J.A., O’Connor, J.W., Tobias, D.J., Mondragon-Ramirez, C., Vorobyov, I., MacKerell, Jr., A.D., Pastor R.W. Update of the CHARMM All-Atom Additive Force Field for Lipids: Validation on Six Lipid Types // Journal of Physical Chemistry B. – 2010. – V. 114, No23. – Р. 7830–7843. DOI:10.1021/jp101759q; Abraham M.J., Murtola T., Schulz R., Páll S., Smith J.C., Hess B., Lindahl E. GROMACS: High performance molecular simulations through multi–level parallelism from laptops to supercomputers // SoftwareX. – 2015. – V. 1–2. – P. 19–25. DOI:10.1016/j.softx.2015.06.001.; Zoete V., Cuendet M. A., Grosdidier A., Michielin O. SwissParam: a Fast Force Field Generation Tool For Small Organic Molecules // Journal of Computational Chemistry. – 2011. – V. 32, No 11. – P. 2359–2368. DOI:10.1002/jcc.21816.; Braga C., Travis K. P. A configurational temperature Nosé– Hoover thermostat // The Journal of Chemical Physics.–2005. – V. 123, No 11. – P.123. DOI:10.1063/1.2013227.; Neese F. Software update: The ORCA program system, version 4.0 // Wiley Interdisciplinary Reviews: Computational Molecular Science. – 2017. – Vol. 8, No 1.– P. e1327. DOI:10.1002/wcms.1327.; Bäcktorp C., Örnskov E., Ottosson J., Evertsson E., Remmelgas J., Broo A. Experimental and Quantum Chemical Evaluations of Pyridine Oxidation Under Drug Development Stress Test Conditions // Journal of Pharmaceutical Sciences. –2015. – V. 104 (12). – P. 4355–4364. DOI:10.1002/jps.24685; Szepesi G., Gazdag M., Mihályfi K. Selection of high– performance liquid chromatographic methods in pharmaceutical analysis // Journal of Chromatography A. – 1991. – V. 464. – P. 265–278. DOI:10.1016/s0021-9673(00)94245-6; Gazdag M., Szepesi G., Szeleczki E. Selection of high–performance liquid chromatographic methods in pharmaceutical analysis // Journal of Chromatography A. – 1988. – V. 454. – P. 83–94. DOI:10.1016/s0021-9673(00)88604-5; Carr G.P., Wahlich J.C. A practical approach to method validation in pharmaceutical analysis // Journal of Pharmaceutical and Biomedical Analysis. – 1990. – V. 8 (8–12). – P. 613–618. DOI:10.1016/0731-7085(90)80090-c; Jenke D.R. Chromatographic method validation: a review of common practices and procedures // Journal of Liquid Chromatography & Related Technologies. – 1996. – V. 19 (5). – P. 719–736. DOI:10.1080/10826079608005533; Iram F., Iram H., Iqbal A., Husain A. Forced Degradation Studies // Journal of Analytical & Pharmaceutical Research. – 2016. – V. 3, No 6. – P. 73. DOI:10.15406/japlr.2016.03.00073; Blessy M., Patel R.D., Prajapati P.N., Agrawal Y.K. Development of forced degradation and stability indicating studies of drugs – A review // Journal of Pharmaceutical Analysis. – 2014. – V. 4, No 3. – P. 159–165. DOI:10.1016/j.jpha.2013.09.003; Alsante K.M., Ando A., Brown R., et al. The role of degradant profiling in active pharmaceutical ingredients and drug products // Advanced Drug Delivery Reviews. – 2007. – V. 59, No1. – P. 29–37. DOI:10.1016/j.addr.2006.10.006; Piechocki J.T., Thoma K. Pharmaceutical Photostability and Stabilization Technology, Informa Healthcare. – CRC Press, publ. 2019. – 445p.; Singh R, Rehman Z. Current trends in forced degradation study for pharmaceutical product development. Journal of Pharmaceutical Education and Research. 2012;3(1):54–63.; https://www.pharmpharm.ru/jour/article/view/729

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    Academic Journal
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    Academic Journal

    Πηγή: Управління, економіка та забезпечення якості в фармації; № 4(52) (2017): Управління, економіка та забезпечення якості в фармації; 29-34
    Upravlìnnâ, ekonomìka ta zabezpečennâ âkostì v farmacìï; № 4(52) (2017): Upravlìnnâ, ekonomìka ta zabezpečennâ âkostì v farmacìï; 29-34
    Управление, экономика и обеспечение качества в фармации; № 4(52) (2017): Управление, экономика и обеспечение качества в фармации; 29-34

    Περιγραφή αρχείου: application/pdf

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    Conference

    Συγγραφείς: Benassi, E.

    Relation: Химия и химическая технология в XXI веке : материалы XIX Международной научно-практической конференции студентов и молодых ученых имени профессора Л. П. Кулёва, 21-24 мая 2018 г., г. Томск. — Томск, 2018.; http://earchive.tpu.ru/handle/11683/49739

    Διαθεσιμότητα: http://earchive.tpu.ru/handle/11683/49739

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    Academic Journal

    Πηγή: Regulatory Research and Medicine Evaluation; № 2 (2015); 9-12 ; Регуляторные исследования и экспертиза лекарственных средств; № 2 (2015); 9-12 ; 3034-3453 ; 3034-3062 ; undefined

    Περιγραφή αρχείου: application/pdf

    Relation: https://www.vedomostincesmp.ru/jour/article/view/32/16; Stability Testing of New Drug Substances and Products, Q1A(R2) // International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2_Guideline.pdf.; Stability Testing For New Dosage Forms, QIC. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1C/Step4/Q1C_Guideline.pdf.; Stability Testing of Existing Active Ingredients and Related Finished Products (CPMP/QWP/122/02 Rev. 1 corr). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003466.pdf.; Правила составления, изложения и оформления нормативной документации на фармацевтические субстанции. Правила составления, изложения и оформления нормативной документации на препараты в лекарственной форме «Таблетки». В кн.: Миронов АН, ред. Руководство по экспертизе лекарственных средств. Т. 2. М.: Гриф и К; 2013.; Государственная фармакопея Российской Федерации. 12-е изд. Часть 1. М.: Научный центр экспертизы средств медицинского применения; 2008.; European Pharmacopoeia. 8th ed. Available from: http://online.edqm.eu/entry.htm.; Инструкция по проведению работ по изучению устойчивости лекарственных средств-субстанций к воздействию влаги и других химически активных компонентов воздуха. (И 64-15-77). Утв. Министерством медицинской промышленности 10 октября 1977 г. М.; 1977.; Stability Testing: Photostability Testing of New Drug Substances and Products, Q1B. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1B/Step4/Q1B_Guideline.pdf.; Yoshioka S. et al. Quinine Actinometry as a method for calibrating ultraviolet radiation intensity in light-stability testing of pharmaceuticals. Drug Development and Industrial Pharmacy 1994; 20(13), 2049-2062.; ИСО 10977 (1993). Фотография. Обработанные цветные фотопленки и бумажные позитивы. Методы измерения устойчивости изображения.; Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances (CPMP/QWP/609/96 Rev. 2). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003468.pdf.; https://www.vedomostincesmp.ru/jour/article/view/32; undefined

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    Academic Journal
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