HUMAN NORMAL IMMUNOGLOBULIN DRUGS: ISSUES OF EFFICIENCY AND SAFETY OF MEDICAL USE

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Issue: 
11
Year: 
2015

V. Ivanov; V. Mosyagin; M. Vdovichenko; E. Kudasheva; V. Bondarev; I. Borisevich Scientific Centre for Expert Evaluation of Medicinal Products under the Ministry of Health of the Russian Federation, Moscow

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: 
human normal immunoglobulin
quality
efficacy
safety
expert evaluation



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References: 
  1. Obschaja farmakopejnaja stat'ja «Immunoglobuliny cheloveka»: utv. Prikazom Minzdrava Rossii ot 21.11.2014 №768.
  2. 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.
  3. Nikonov A.G. Syvorotochnaja bolezn' i passivnyj immunitet / M.: Medgiz, 1948; 172 s.
  4. Empson M., Sinclair J., O'Donnell J. et al. The assessment and management of primary antibody deficiency // NZ Med. J. – 2004; 117 (1195): U914.
  5. Polson A. Immune globulin and its use in profilaxis and therapy of infectious diseases // S. Afr. Med. J. – 1957; 31 (49): 1242–4.
  6. Bonagura V. Using intravenous immunoglobulin (IVIG) to treat patients with primary immune deficiency disease // J. Clin. Immunol. – 2013; 33 (Issue 2, Suppl.): 90–4.
  7. Appropriate uses of human immunoglobulin in clinical practice: Memorandum from an IUIS/WHO meeting // Bulletin of the WHO. – 1982; 60 (1).
  8. The selection and use of essential medicines // WHO Techn. Rep. Ser. – 2007; 950.
  9. Zubkova N.V. Biotehnologicheskie aspekty effektivnoj i bezopasnoj pererabotki donorskoj plazmy: problemy i perspektivy // Biopreparaty. – 2014; 1 (49): 4–10.
  10. Carrock S., Kerr J., Behr-Gross M. et al. European consensus proposal for immunoglobulin therapies // Eur. J. Immunol. – 2014; 44 (8): 2207–14.
  11. 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
  12. Gosudarstvennyj reestr lekarstvennyh sredstv. URL: http://grls.rosminzdrav.ru/grls.aspx
  13. Concept paper on Guidline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) and Core SmPC: EMA/CHMP/BPWP/572805/2013.
  14. O vnesenii izmenenij v Federal'nyj zakon ot 22.12.2014 №429-FZ «Ob obraschenii lekarstvennyh sredstv».
  15. ICH (2011). Preclinical safety evolution of biotechnology-derived pharmaceuticals. ICH Harmonised Tripartite Guideline, ICH S6 (R1).
  16. Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg): EMA/CHMP/BPWP/94033/2007 rev. 2. 17.
  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.
  18. Immune Globulin (Human). URL: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM371376.pdf
  19. Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration: EMA/CHMP/BPWP/143744/2011 rev. 1.
  20. Recommendations for the production, control and regulation of human plasma for fractionation // WHO Techn. Rep. Ser. – 2007; 941.