Search Results - "Glassman, Fiona"
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Subcutaneous administration of Lyso-phosphatidylserine nanoparticles induces immunological tolerance towards Factor VIII in a Hemophilia A mouse model
Published in International journal of pharmaceutics (05-09-2018)“…[Display omitted] A major complication with enzyme replacement therapy of Factor VIII (FVIII) in Hemophilia A (HA) is the development of anti-drug antibodies…”
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Efficacy, pharmacokinetics, and safety of subcutaneous C1-esterase inhibitor as prophylaxis in Japanese patients with hereditary angioedema: Results of a Phase 3 study
Published in Allergology international (01-07-2023)“…Hereditary angioedema (HAE) is a rare and potentially life-threatening genetic disorder characterized by recurrent attacks of angioedema. HAE types I and II…”
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Rational design of a nanoparticle platform for oral prophylactic immunotherapy to prevent immunogenicity of therapeutic proteins
Published in Scientific reports (08-09-2021)“…The safety and efficacy of several life-saving therapeutic proteins are compromised due to their immunogenicity. Once a sustained immune response against a…”
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Biological Function and Immunotherapy Utilizing Phosphatidylserine-based Nanoparticles
Published in Immunological investigations (02-10-2020)“…Phosphatidylserine (PS) is a naturally occurring anionic phospholipid that is primarily located in the inner leaflet of eukaryotic cell membranes. The role of…”
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Phosphatidylserine Is Not Just a Cleanup Crew but Also a Well-Meaning Teacher
Published in Journal of pharmaceutical sciences (01-08-2018)“…Phosphatidylserine (PS) exposure during apoptosis leads to silent clearance of cells without adverse immune reactions to self-proteins. Given the biological…”
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Pharmacokinetic/pharmacodynamic modeling for dose selection for the first‐in‐human trial of the activated Factor XII inhibitor garadacimab (CSL312)
Published in Clinical and translational science (01-03-2022)“…Factor XII (FXII) is a serine protease involved in multiple cascades, including the kallikrein–kinin system. It may play a role in diseases in which the…”
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Population Pharmacokinetic/Pharmacodynamic Analysis Of Garadacimab, In Patients With Hereditary Angioedema
Published in Journal of allergy and clinical immunology (01-02-2024)Get full text
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A Phase 1, Randomized, Open-label, Parallel-group Study Comparing Pharmacokinetic Properties Of Garadacimab Administered By Subcutaneous Pre-filled Syringe Assembled To Autoinjector/Pre-filled Pen Versus Pre-filled Syringe Assembled To Needle Safety Device In Healthy Adults
Published in Journal of allergy and clinical immunology (01-02-2024)Get full text
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Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous and Intravenous Garadacimab Following Single‐Dose Administration in Healthy Japanese and White Adults
Published in Journal of clinical pharmacology (24-11-2024)“…Garadacimab, an activated factor XII (FXIIa) inhibitor monoclonal antibody, is being evaluated for the long‐term prophylaxis of hereditary angioedema. Here, we…”
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Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
Published in The Lancet (British edition) (01-04-2023)“…Hereditary angioedema is a rare and potentially life-threatening genetic disease that is associated with kallikrein–kinin system dysregulation. Garadacimab…”
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Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump
Published in Immunotherapy (01-11-2022)“…A novel, Investigational Wearable Infusor (IWI) was evaluated in a randomized, controlled, crossover, open-label study to determine if its delivery of…”
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Phosphatidylserine-based Nanoparticles for Tolerance Induction Towards Therapeutic Proteins
Published 01-01-2018“…Phosphatidylserine (PS) is the most abundant negatively charged phospholipid in the cell membrane. Despite comprising 12% of total phospholipid and being…”
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Dissertation