Диссертация (1141371), страница 21
Текст из файла (страница 21)
Терешкина, Т.А. Гуськова //Фармация. - 2007. - №6. - С.6-9.23. Тихонов А.И. Биофармация / А.И. Тихонов, Т.Г. Ярных, И.А. Зупанец, О.С.Данькевич, Е.Е. Богуцкая, Н.В. Бездетно, Ю.Н. Азаренко. – X.: «НФаУ», 2003. –240 с.24. Фармацевтическая разработка: концепция и практические рекомендации: научнопрактическое руководство для фармацевтической отрасли / под ред. С. Н.Быковского, И. А. Василенко, Н. Б. Деминой и др.
– М.: Изд-во Перо, 2015. - 472с.25. Фармацевтический сектор: основы законодательства в Европейском Союзе / Авт.составители Н.А. Ляпунов, В.А. Усенко, А.Л. Спасокукоцкий, Е.П. Безуглая. – К.:МОРИОН, 2002. – С. 7-65.26. Харенко, Е.А. Мукоадгезивные лекарственные формы / Е.А. Харенко, Н.И.Ларионова, Н.Б. Демина // Хим.-фарм. журнал. - 2009.
- Т.43, №4. - С.21-29.27. Физическая и коллоидная химия/ Н.Н. Мушкамбаров. – М.: ООО «Медицинскоеинформационное агентство», 2008. – 295 с.28. 70 тысяч молодых людей ежегодно умирают в России от наркотиков//Interfax.ru:междунар.информ.группа.2014.14янв.URL:http://www.interfax.ru/russia/351424 (дата обращения: 20.08.2016)29. Alqurshi, A., Amorphous formulation and in vitro performance testing ofinstantlydisintegrating buccal tablets for the emergency delivery of naloxone / Alqurshi, A.,Kumar, Z., McDonald, R. et al.
// Mol Pharm. 2016 May 2;13(5):1688-98. doi:10.1021/acs.molpharmaceut.6b00096.30. Aurora R., et al, ‘Development of nasal delivery systems: a review’ / Drug Del. Tech.2(7), 70-73 (2002)31. Avetian G.K., Fiuty P., Mazzella S., Koppa D., Heye V., Hebbar P. Useof naloxone nasal spray 4 mg in the community setting: a survey of use by communityorganizations//CurrMed10.1080/03007995.2017.1334637.ResOpin.2017Jun7:1-4.doi:13632. Bagel, S.
Extension of in-use stability of preservative-free nasalia / Bagel S,Wiedemann B. //. Europ J Pharmaceutics and Biopharmaceutics. 2004, (57): 353–358.33. Bailey, A. Naloxone for opioid overdose prevention: pharmacists role in communitybased practice settings / Bailey, A., Wermeling, D. // Ann Pharmacother 2014, 48: 601–606.34. Bailey, J. The under recognized toll of prescription opioid abuse on young children /Bailey, J., Campagna, E.
and Dart, R. // Ann Emerg Med 2009, 53: 419–424.35. Barton, E. Efficacy of intranasal naloxone as a needleless alternative for treatment ofopioid overdose in the prehospital setting / Barton, E., Colwell, C., Wolfe, T., Fosnocht,D., Gravitz, C., Bryan, T. et al. // J Emerg Med 2005, 29: 265–271.36. Barton, E. Intranasal administration of naloxone by paramedics / Ramos, J., Colwell, C.,Benson, J., Baily, J. and Dunn, W. // Prehosp Emerg Care 2002, 6: 54–58.37. Beletsky, L. Prevention of fatal opioid overdose. / Beletsky, L., Rich, J.D., Walley,A.Y. // JAMA308, 2012, 1863–1864.38.
Belz, D. Naloxone use in a tiered-response emergency medical services system / Belz,D., Lieb, J., Rea, T., Eisenberg, M.S. // Prehosp. Emerg. Care 10, 2006, 468–471.39. Bond, G. The growing impact of pediatric pharmaceutical poisoning / Bond, G.,Woodward, R. and Ho, M. // J Pediatr 2012, 160: 265–270.40. British Pharmacopoeia 2009. – Volume III. – Naloxone Injection. – 2 p.41. Brunton, L., Chabner, B., Knollman, B. (Eds.). Goodman & Gilman’s ThePharmacological Basis of Therapeutics.
McGraw Hill, New York.CDC, 2012.42. Buajordet, I. Adverse events after naloxone treatment of episodes of suspected acuteopioid overdose / Buajordet, I., Næss, A., Jacobsen, D. and Brørs, O. // Eur J EmergMed 2004, 11: 19–23.43.Bunn, T. and Slavova, S. (2012) Drug overdose morbidity and mortality in Kentucky,2000–2010. Kentucky Injury and Prevention Center.44. Calcaterra, S., Glanz, J., Binswanger, I.A., 2013.
National trends in pharmaceuticalopioid related overdose deaths compared to other substance related overdose deaths:1999–2009. Drug Alcohol Depend. 131, 263–270.13745. Cantwell, K. The relationship between naloxone dose and key patient variables in thetreatment of non-fatal heroin overdose in the pre-hospital setting / Cantwell, K., Dietze,P. and Flander, L. // Resuscitation 2005, 65: 315–319.46. Committee for medicinal products for human use (CHMP). Guideline on thepharmaceutical quality of inhalation and nasal products.
London: European MedicinesAgency; 2006.47. Consumer Product Safety Ccommission 16 CFR Part 1700, CPSC Docket No. 2012–0005, Requirements for child-resistant packaging: Products containing imidazolinesequivalent to 0.08 milligrams or more. December 12, 2012.48.Cordray S., Harjo J.B., Miner L.
Comparison of intranasal hypertonic dead seasaline spray and intranasal aqueous triamcinolone spray in seasonal allergic rhinitis //Ear Nose Throat J. 2005 Jul;84(7):426-30.49. Costantino, H. Intranasal delivery: physicochemical and therapeutic aspects /Costantino, H., Illum, L., Brandt, G., Johnson, P. and Quay, S. // Int J Pharm 2007, 337:1–24.50.
CPMP/EWP/QWP/1401/98 Rev. 1/ Corr. –Guideline on the investigation ofbioequivalence, 2010.51. CPMP/QWP/122/02 Rev 1 corr. – Guideline on stability testing: stability testing ofexisting active substances and related finished products, 2003.52. CРМР/ICH/367/96 (ICH Topic Q6A). – Note for Guidance Specifications: TestProcedures and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances, 2000.53. Dale, O.
Intranasal midazolam: a comparison of two delivery devices in humanvolunteers / Dale, O., Nilsen, T., Loftsson, T., Tоnnesen, H.H., Klepstad, P., Kaasa, S.,Holand, T., Djupesland, P.G. // J. Pharm. Pharmacol. 2006, 58, 1311–1318.54. Davis S., et al, ‘Absorption enhancers for nasal drug delivery’, Clin. Pharm., 42(13),1107-28 (2003)55. Davis, C.
Changing Law from Barrier to Facilitator of Opioid OVerdose Prevention /Davis, C., Webb, D. and Burris, S. // J Law Med Ethics 2013, 41(Suppl. 1): 33–36.13856. Dayal P., et al, ‘Evaluation of different parameters that effect droplet size distributionfrom nasal sprays using the Malvern Spraytech, J. Pharm. Sci., 93: 1725-1742 (2004).57. Degenhardt, L. Mortality among regular or dependent users of heroin and other opioids:a systematic review and meta-analysis of cohort studies / Degenhardt, L., Bucello, C.,Mathers, B., Briegleb, C., Ali, H., Hickman, M., McLaren, J.
// Addiction 2011, 106,32–51.58. Djupesland, P.G.. The nasal approach todelivering treatment for brain diseases: ananatomic physiologic, and delivery technology overview / Djupesland, P.G., Messina,J.C., Mahmoud, R.A. // Ther. Deliv. 2014, 5, 709–733.59. Doe-Simkins, M. Saved by the nose: by stander-administered intranasal naloxonehydrochloride for opioid overdose / Doe-Simkins, M., Walley, A.Y., Epstein, A.,Moyer, P. // Am. J. Public Health 2009, 99, 788–791.60.
Dowling, J. Population pharmacokinetics of intravenous, intramuscular, and intranasalnaloxone in human volunteers / Dowling, J., Isbister, G., Kirkpatrick, C., Naidoo, D.and Graudins, A. // Ther Drug Monit 2008, 30: 490–496.61. Dwyer, K. Opioid education and nasal naloxone rescue kits in the emergencydepartment / Dwyer, K., Walley, A.Y., Langlois, B.K., Mitchell, P.M., Nelson, K.P.,Cromwell, J., Bernstein, E.
// West. J. Emerg. Med. 2015, 16, 381–384.62. EMEA/CHMP/QWP/396951/2006. – Guideline on Excipients in the Dossier forApplication for Marketing Authorisation of a Medicinal Product, 2007.63. EMEA/СHМР/167068/2004 – ICH (ICH Topic Q8). – Note for Guidance onPharmaceutical Development, 2006.64. EMEA-Heath Canada: Joint Guideline on the Pharmaceutical Quality of Inhalation andNasal Products EMEA/CHMP/QWP/49313/200565.
European Pharmacopoeia 8.0 ed. 2014. 3162 c.66. Fagot Ch and Marx D. Intranasal vaccines -a platform technology for an innovativevaccine industry. December 2011, Express Pharma India, access at http://archive.expresspharmaonline.com/20111231/research02.shtml13967.Fareed A., Buchanan-Cummings A.M., Crampton K., Grant A., Drexler K.
Reversal ofoverdose on fentanyl being illicitly sold as heroin with naloxone nasal spray: A casereport. // Am J Addict. 2015 Aug;24(5):388-90. doi: 10.1111/ajad.12230.68.Farina, D. Regulatory aspects of nasal and pulmonary spray drug products/, published inHandbook of non-invasive drug delivery systems, Ed. V.Kulkarni, Elsevier, Oxford,UK, 247-290 (2010).69. FDAIIG(InactiveIngredientGuidance),http://accessdata.fda.gov/scripts/cder/iig/index.cfm70.Floettmann E., Bui K., Sostek M., Payza K., Eldon M. Pharmacologic Profile ofNaloxegol, a Peripherally Acting µ-Opioid Receptor Antagonist, for the Treatment ofOpioid-Induced Constipation // J Pharmacol Exp Ther.
2017 May;361(2):280-291. doi:10.1124/jpet.116.23906171. Foo M.Y. The influence of spray properties on intranasal deposition / Foo MY, ChengYS, Su WC, Donovan MD // J Aerosol Med. 2007, 20(4): 495-50872. Gro D. The COMOD-System – a preservative free drug therapy against glaucoma. 321328, in Org l/Flammer (Editors): Pharmacotherapie in glaucoma, Bern 2000.73.
Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and SprayDrug Products - Chemistry, Manufacturing, and Controls Documentation. USDepartment of Health and Human Services, Food and Drug Administration, Center forDrug Evaluation and Research (CDER). Rockville, MD; 2002.74. Guideline 3AQ11a. – Specifications and Control Tests on the Finished Product.75. Guideline on pharmaceutical development of medicines for paediatric use, 3 January2013, EMA/CHMP/QWP/805880/2012 Rev. 276. Guideline on Plastic Immediate Packaging Materials. – CPMP/QWP/4359/03,EMEA/CVMP/205/04. – London, 19 May 2005.
– 11 p.77. Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products. –EMEA/CHMP/QWP/49313/2006 corr. – London, 21 June 2006. – 25 p.78. Hasegawa, K. Epidemiology of emergency department visits for opioid overdose: Apopulation-based study / Hasegawa, K., Brown, D., Tsugawa, Y and Camargo, C. //Mayo Clin Proc 2014, 89: 461–471.14079. Havens, J. Prevalence of opioid analgesic injection among rural nonmedical opioidanalgesic users / Havens, J., Walker, R. and Leukefeld, C. // Drug Alcohol Depend2007, 87: 98–102.80. Hertz, S., 2012. Naloxone for Outpatient Use: Data Required to Support an NDA(accessedon05.30.14.).http://www.fda.gov/downloads/Drugs/NewsEvents/UCM300874.pdf.81.
![](https://s.studizba.com/z.php?f=/templates/si/i/noavatar.png&w=100&h=100&t=1"){kind=avatar}
