ENHANZE<sup>®</sup> drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase PH20
Tóm tắt
Từ khóa
Tài liệu tham khảo
Alexion Pharmaceuticals I. (2017). Alexion and Halozyme Enter License Agreement for ENHANZE Technology. Available at: http://files.shareholder.com/downloads/ALXN/6264479688x0x966094/4E5A51B2-4A6E-4C45-83C1-1F8B8373B8C0/ALXN_News_2017_12_7_General.pdf [last accessed 7 Sep 2018].
Alexion Pharmaceuticals I. (2018). Alexion development programs. Available at: http://alexion.com/research-development/development-programs [last accessed 19 Nov 2018].
Baxter BioScience. (2014). HyQvia Blood Products Advisory Committee Meeting. Available at: https://wayback.archive-it.org/7993/20170406182957/https:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM407013.pdf [last accessed September 2018].
Duran-Reynals F, 1928, Comptes Rendu Hebdomadaire de Séances et Mémoires de la Société deBiologie, 99, 6
European Medicines Agency. (2013a). HyQvia EPAR Public Assessment Report. Available at: https://www.ema.europa.eu/documents/assessment-report/hyqvia-epar-public-assessment-report_en.pdf [last accessed 19 Nov 2018].
European Medicines Agency. (2013b). HyQvia EPAR summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002491/WC500143851.pdf [last accessed 31 May 2018].
European Medicines Agency. (2018a). DARZALEX summary of product characteristics. Available at: https://www.ema.europa.eu/documents/product-information/darzalex-epar-product-information_en.pdf [last accessed 19 Nov 2018].
European Medicines Agency. (2018b). Herceptin summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf [last accessed 25 May 2018].
European Medicines Agency. (2018c). MabThera summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000165/WC500025821.pdf [last accessed 31 May 2018].
Garrun D. (2013). Breaking barriers – the potential of subcutaneous drug delivery. Available at: https://www.drugdevelopment-technology.com/features/featurehalozyme-roche-subcutaneous-drug-delivery-platform/ [last accessed Nov 13].
Great Ormond Street Hospital. (2017). Immunoglobulin infusions: intravenous and subcutaneous. Available at: https://www.gosh.nhs.uk/health-professionals/clinical-guidelines/immunoglobulin-infusions-intravenous-and-subcutaneous#Rationale [last accessed Nov 15].
Halozyme Therapeutics Inc. (2018). FDA accepts biologics license application for subcutaneous formulation of herceptin. Available at: https://www.halozyme.com/investors/news-releases/news-release-details/2018/FDA-Accepts-Biologics-License-Application-For-Subcutaneous-Formulation-Of-Herceptin/default.aspx [last accessed 13 Aug 2018].
Kang DW, 2013, Controll Release Newsl, 30, 9
Roche Canada. (2018a). Pr HERCEPTIN® SC product monograph. Available at: http://www.rochecanada.com/content/dam/roche_canada/en_CA/documents/Research/ClinicalTrialsForms/Products/ConsumerInformation/MonographsandPublicAdvisories/Herceptin/HerceptinSC_PM_E.pdf [last accessed Sep 2018].
Roche Canada. (2018b). Pr RITUXAN® SC product monograph. Available at: http://www.rochecanada.com/content/dam/roche_canada/en_CA/documents/Research/ClinicalTrialsForms/Products/ConsumerInformation/MonographsandPublicAdvisories/RituxanSC/RituxanSC_PM_E.pdf [last accessed 10 August 2018].
Silverstein SM, 2012, J Appl Res, 12, 1
U.S. Food and Drug Administration. (2003). United States Food and Drug Administration clinical review of NDA 21-640 (Vitrase®). Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-640_Vitrase_Medr.pdf [last accessed 31 May 2018].
U.S. Food and Drug Administration. (2005). HYLENEX prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s009lbl.pdf [last accessed 15 May 2018].
U.S. Food and Drug Administration. (2012). September 12, 2014 Approval Letter - HYQVIA. Available at: http://wayback.archive-it.org/7993/20170723025727/https:/www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm414148.htm [last accessed 19 Nov 2018].
U.S. Food and Drug Administration. (2014). HYQVIA prescribing information. 2014. Available at: https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM414440.pdf [last accessed 15 Nov 2018].
U.S. Food and Drug Administration. (2017a). ODAC briefing document rituximab and hyaluronidase. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM548659.pdf [last accessed 15 May 2018].
U.S. Food and Drug Administration. (2017b). RITUXAN HYCELA FDA approval. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564235.htm [last accessed 7 May 2018].
U.S. Food and Drug Administration. (2017c). RITUXAN HYCELA prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf [last accessed 31 May 2018].
U.S. Food and Drug Administration. (2017b). Rituximab and hyaluronidase injection, for subcutaneous use (rituximab SC). Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM551240.pdf [last accessed 11/07/18].
Veneziale RW, 2014, Nonclinical studies to assess possible effects of antibodies to rHuPH20 on the endogenous counterpart
World Health Organization. (2003). WHO Guidelines on transmissible spongiform encephalopathies in relation to biological and pharmaceutical products. Available at: http://www.who.int/biologicals/publications/en/whotse2003.pdf?ua=1&ua=1 [last accessed 31 May 2018].