Efficacy and safety of a new immunoglobulin G product, Gammaplex®, in primary immunodeficiency diseases
Version of Record online: 10 NOV 2010
© 2010 The Authors. Clinical and Experimental Immunology © 2010 British Society for Immunology
Clinical & Experimental Immunology
Volume 162, Issue 3, pages 510–515, December 2010
How to Cite
Moy, J. N., Scharenberg, A. M., Stein, M. R., Suez, D., Roberts, R. L., Levy, R. J., Ballow, M., Fasano, M. B., Dash, C. H. and Leach, S. J. (2010), Efficacy and safety of a new immunoglobulin G product, Gammaplex®, in primary immunodeficiency diseases. Clinical & Experimental Immunology, 162: 510–515. doi: 10.1111/j.1365-2249.2010.04247.x
- Issue online: 10 NOV 2010
- Version of Record online: 10 NOV 2010
- Accepted for publication 19 July 2010
- 6US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency. Draft guidance November 2005 (finalized June 2008).
- 7Committee for Proprietary Medicinal Products. Note for guidance on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIG). London: 29 June 2000, CPMP/BPWG/388.95 rev. 1.
- 11Survival of IgG subclasses following administration of intravenous gammaglobulin in patients with primary immunodeficiency diseases. In: MorellA, NydeggerUE, eds. Clinical use of intravenous immunoglobulins. London: Academic Press Inc., 1986:77–85., , et al.