Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients

An available supply of intravenous immunoglobulin (IVIG) is essential for individuals with primary humoral immunodeficiency. A shortage in 1997 prompted the Food and Drug Administration (FDA) to revise guidelines for the licensure, production, and distribution of new IVIG products, including the sta...

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Detalles Bibliográficos
Autores principales: Schroeder, H. W., Dougherty, C. J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer-Verlag 2012
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501191/
https://www.ncbi.nlm.nih.gov/pubmed/22968971
http://dx.doi.org/10.1007/s15010-012-0323-9
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author Schroeder, H. W.
Dougherty, C. J.
author_facet Schroeder, H. W.
Dougherty, C. J.
author_sort Schroeder, H. W.
collection PubMed
description An available supply of intravenous immunoglobulin (IVIG) is essential for individuals with primary humoral immunodeficiency. A shortage in 1997 prompted the Food and Drug Administration (FDA) to revise guidelines for the licensure, production, and distribution of new IVIG products, including the standardization of United States clinical trials regarding endpoints for safety, efficacy, and pharmacokinetics. The following review is intended to present current information and results of clinical trials in patients with primary immunodeficiency treated with IVIG products currently licensed or awaiting licensure in the United States. The data presented are compiled from published clinical trials and prescribing information generated by manufacturers.
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spelling pubmed-35011912012-11-26 Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients Schroeder, H. W. Dougherty, C. J. Infection Review An available supply of intravenous immunoglobulin (IVIG) is essential for individuals with primary humoral immunodeficiency. A shortage in 1997 prompted the Food and Drug Administration (FDA) to revise guidelines for the licensure, production, and distribution of new IVIG products, including the standardization of United States clinical trials regarding endpoints for safety, efficacy, and pharmacokinetics. The following review is intended to present current information and results of clinical trials in patients with primary immunodeficiency treated with IVIG products currently licensed or awaiting licensure in the United States. The data presented are compiled from published clinical trials and prescribing information generated by manufacturers. Springer-Verlag 2012-09-12 2012 /pmc/articles/PMC3501191/ /pubmed/22968971 http://dx.doi.org/10.1007/s15010-012-0323-9 Text en © The Author(s) 2012 https://creativecommons.org/licenses/by/4.0/ This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Review
Schroeder, H. W.
Dougherty, C. J.
Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients
title Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients
title_full Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients
title_fullStr Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients
title_full_unstemmed Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients
title_short Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients
title_sort review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501191/
https://www.ncbi.nlm.nih.gov/pubmed/22968971
http://dx.doi.org/10.1007/s15010-012-0323-9
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