HUMAN NORMAL IMMUNOGLOBULIN DRUGS: ISSUES OF EFFICIENCY AND SAFETY OF MEDICAL USE
- Authors: Ivanov V.1, Mosyagln V.1, Vdovichenko M.1, Kudasheva E.1, Bondarev V.1, Borisevich I.1
-
Affiliations:
- Scientific Centre for Expert Evaluation of Medicinal Products under the Ministry of Health of the Russian Federation
- Issue: Vol 26, No 11 (2015)
- Pages: 17-20
- Section: Articles
- URL: https://journals.eco-vector.com/0236-3054/article/view/116381
- ID: 116381
Cite item
Open Access
Access granted
Abstract
Presents historical and contemporary aspects of drugs immunoglobulin human normal, requirements pre-clinical and clinical studies, analysis of medical application instructions, regulatory documents on the treatment of these drugs.
Keywords
Full Text
About the authors
V. Ivanov
Scientific Centre for Expert Evaluation of Medicinal Products under the Ministry of Health of the Russian Federation
Email: ivanov@expmed.ru
V. Mosyagln
Scientific Centre for Expert Evaluation of Medicinal Products under the Ministry of Health of the Russian Federation
M. Vdovichenko
Scientific Centre for Expert Evaluation of Medicinal Products under the Ministry of Health of the Russian Federation
E. Kudasheva
Scientific Centre for Expert Evaluation of Medicinal Products under the Ministry of Health of the Russian Federation
V. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products under the Ministry of Health of the Russian Federation
I. Borisevich
Scientific Centre for Expert Evaluation of Medicinal Products under the Ministry of Health of the Russian Federation
References
- Общая фармакопейная статья «Иммуноглобулины человека»: утв. Приказом Минздрава России от 21.11.2014 №768.
- Cohn E., Strong L., Mulford D. et al. Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids // J. Am. Chem. Soc. -1946; 68: 459-75.
- Никонов А.Г. Сывороточная болезнь и пассивный иммунитет / М.: Медгиз, 1948; 172 с.
- Empson M., Sinclair J., O'Donnell J. et al. The assessment and management of primary antibody deficiency // NZ Med. J. - 2004; 117 (1195): U914.
- Polson A. Immune globulin and its use in profilaxis and therapy of infectious diseases // S. Afr. Med. J. - 1957; 31 (49): 1242-4.
- Bonagura V. Using intravenous immunoglobulin (IVIG) to treat patients with primary immune deficiency disease // J. Clin. Immunol. - 2013; 33 (Issue 2, Suppl.): 90-4.
- Appropriate uses of human immunoglobulin in clinical practice: Memorandum from an IUIS/WHO meeting // Bulletin of the WHO. - 1982; 60 (1).
- The selection and use of essential medicines // WHO Techn. Rep. Ser. -2007; 950.
- Зубкова Н.В. Биотехнологические аспекты эффективной и безопасной переработки донорской плазмы: проблемы и перспективы // Биопрепараты. - 2014; 1 (49): 4-10.
- Carrock S., Kerr J., Behr-Gross M. et al. European consensus proposal for immunoglobulin therapies // Eur. J. Immunol. - 2014; 44 (8): 2207-14.
- Robert P. IVIG/SCIG: global usage trends. IPOPI Global Leaders Meeting 2011, November 4-5, 2011, London, England. URL: http://www.ipopi.org/uploads/ Patrick% 20Robert.pdf
- Государственный реестр лекарственных средств. URL: http://grls. rosminzdrav.ru/grls.aspx
- Concept paper on Guidline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) and Core SmPC: EMA/ CHMP/BPWP/572805/2013.
- О внесении изменений в Федеральный закон от 22.12.2014 №429-ФЗ «Об обращении лекарственных средств».
- ICH (2011). Preclinical safety evolution of biotechnology-derived pharmaceuticals. ICH Harmonised Tripartite Guideline, ICH S6 (R1).
- Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg): EMA/CHMP/BPWP/94033/2007 rev. 2. 17.
- Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg): EMA/CHMP/ BPWP/410415/2011 rev 1.
- Immune Globulin (Human). URL: http://www.fda.gov/downloads/ BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/ LicensedProductsBLAs/FractionatedPlasmaProducts/UCM371376.pdf
- Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration: EMA/CHMP/BPWP/143744/2011 rev. 1.
- Recommendations for the production, control and regulation of human plasma for fractionation // WHO Techn. Rep. Ser. - 2007; 941.
Supplementary files
