Zobrazeno 1 - 10
of 83
pro vyhledávání: '"Mark R. Stein"'
Autor:
William R. Lumry, James B Harris, Jiang Lin, Elsa Mondou, Kecia L. Courtney, John W. Sleasman, Mark R. Stein, H. James Wedner, I. Hussain
Publikováno v:
Immunotherapy. 11:1371-1386
Aim: This prospective, Phase III study assessed the pharmacokinetics (PK), safety and tolerability of immune globulin subcutaneous, human – klhw 20% solution (IGSC-C 20%) in participants with primary humoral immunodeficiency (PI), compared with imm
Autor:
Nicholas Brodszki, Sudhir Gupta, P. Martin van Hagen, Heinz Leibl, Daniel Suez, Stephen Jolles, Mark R. Stein, Barbara McCoy, Gergely Kriván, Leman Yel, Kenneth Paris, Werner Engl
Publikováno v:
Immunotherapy, 11(12), 1057-1065. Future Medicine Ltd.
Aim: This pooled analysis evaluated the safety and tolerability of the subcutaneous immunoglobulin 20% product, Ig20Gly, in primary immunodeficiency diseases using data from two Phase II/III studies conducted in North America and Europe. Patients & m
Autor:
James N. Moy, Richard L. Wasserman, Isaac Melamed, Miranda Norton, Stephen Jolles, Mark R. Stein
Publikováno v:
Journal of Clinical Immunology
Purpose This phase 3, multicenter, open-label, randomized, two-period, crossover bioequivalence trial evaluated the safety, tolerability, and pharmacokinetics of intravenous immunoglobulins (IVIGs) Gammaplex 5% and Gammaplex 10% in 33 adults and 15 c
Autor:
Gordon Sussman, John Hooper, William R. Lumry, Robert D. Pesek, Roberta Macchia, Santhosh Kumar, Ralph Shapiro, Garrett E. Bergman, James N. Moy, Vladislava Zamfirova, Mark R. Stein, Donald L. McNeil, Hartwig Gajek, Julia Upton, Chaim M. Roifman, Agnes Nemet
Publikováno v:
LymphoSign Journal. 3:99-109
Background: Primary immunodeficiency involving defective antibody formation requires antibody replacement therapy with immunoglobulin products to prevent and reduce infections. Immunoglobulin for intravenous use (IVIG) is a processed blood product wi
Autor:
Sudhir Gupta, Heinz Leibl, Sandor Fritsch, Daniel Suez, I. Hussain, David Gelmont, Kenneth Paris, Mark R. Stein, Barbara McCoy, Leman Yel, Isaac Melamed, Christelle Bourgeois, Amy Darter
Publikováno v:
Journal of Clinical Immunology
Patients with primary immunodeficiency disease (PIDD) typically require life-long intravenous (IV) or subcutaneous (SC) immunoglobulin (Ig) replacement therapy to prevent recurrent infections. The efficacy, safety, and pharmacokinetics of a highly co
Autor:
Andrew J. Grant, Heinz Leibl, Leman Yel, Wendell G. Richmond, Arye Rubinstein, Mark R. Stein, David Gelmont, Richard L. Wasserman, Jennifer M. Puck, Sudhir Gupta, Anoshie Ratnayake, Joseph A. Church, Lisa Kobrynski, Marlies Sharkhawy, Werner Engl, Isaac Melamed
Publikováno v:
Wasserman, RL; Melamed, I; Stein, MR; Engl, W; Sharkhawy, M; Leibl, H; et al.(2016). Long-Term Tolerability, Safety, and Efficacy of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Human Immunoglobulin for Primary Immunodeficiency. JOURNAL OF CLINICAL IMMUNOLOGY, 36(6), 571-582. doi: 10.1007/s10875-016-0298-x. UC Irvine: Retrieved from: http://www.escholarship.org/uc/item/727057th
Journal of Clinical Immunology
Journal of Clinical Immunology
Purpose Treatment of primary immunodeficiency diseases (PIDD) with subcutaneous (SC) infusions of IgG preceded by injection of recombinant human hyaluronidase (rHuPH20) (IGHy) to increase SC tissue permeability was evaluated in two consecutive, prosp
Autor:
Carrie Hames, John W. Sleasman, Jiang Lin, Mark R. Stein, H. James Wedner, Montse Querolt, James B. Harris, William R. Lumry, Elsa Mondou, Iftikhar Hussain
Publikováno v:
Journal of Allergy and Clinical Immunology. 145:AB31
Autor:
William R. Lumry, Elsa Mondou, Iftikhar Hussain, John W. Sleasman, Montse Querolt, Mark R. Stein, H. James Wedner, James B. Harris, Jiang Lin, Carrie Hames
Publikováno v:
Journal of Allergy and Clinical Immunology. 145:AB71
Autor:
Werner Engl, Christopher J. Rabbat, Sudhir Gupta, Kenneth Paris, I. Hussain, Mark R. Stein, Barbara McCoy, Leman Yel
Publikováno v:
Annals of Allergy, Asthma & Immunology. 123:271-279.e1
Background The subcutaneous immune globulin (SCIG) 20% product, Ig20Gly, was shown to be efficacious and well tolerated in 2 phase 2/3 North American and European studies at infusion volumes up to 60 mL/site and rates up to 60 mL/h/site in patients w
Autor:
D. Suez, Sudhir Gupta, Kenneth Paris, I. Hussain, Leman Yel, Mark R. Stein, Barbara McCoy, P. Wang
Publikováno v:
Annals of Allergy, Asthma & Immunology. 121:S48-S49
Introduction Subcutaneous immune globulin 20%, Ig20Gly, was well tolerated in the phase 2/3 North American study in patients with primary immunodeficiency diseases (PIDD). Here we analyze the safety, tolerability, and infusion parameters by age group