혈장 유래 의약품의 바이러스 안전성 검증

References

1. Med. Postgrad v.29 수혈로 전파되는 바이러스 질환 김현옥
2. Med. Postgrad v.29 혈장으로 만드는 의약품 이성민;김인섭
3. Dev. Biol. Stand v.2 The effect of freeze-drying on the potency and stability of live varicella virus vaccine Bennett, P. S.;R. Z. Maigetter;M. G. Olson;P. J. Provost;E. M. Scatergood;T. L. Schfield
4. Blood Rev. v.2 Infectious complications of blood transfusion Berkman, S. A.
5. Biologicals v.26 Virus validation of pH 4-treated human immunoglobulin products produced by the Cohn fractionation process Bos, O. J. M.;D. G. J. Sunye;C. E. F. Nieuweboer;F. A. C. van Engelenburg;H. Schuitemaker;J. Over
6. J. Am Chem. Soc. v.68 Preparation and properties of serum and ;lasma proteins. Ⅳ. A system for the separation into fractions of the proteins and lipoprotein components of biological tissues and fluids Cohn, E. J.;L. E. Strong;W. L. Hughes Jr;D. J. Mulford;J. N. Ashworth;M. Melin;H. L. Taylor
7. Blood separation and plasma fractionation Viral contamination of human plasma and procedures for preventing virus transmission by plasma products Cuthbertson, B.;K. G. Reid;P. R. Foster;J. R. Harris(ed.)
8. Biologicals v.24 Improvement of virus safety of a S/D-treated factor Ⅷ concentrate by additional dry heat treatment at 100℃ Dichtelmuller, H.;D. Rudnick;B. Breuer;R. Kotitschke;M. Kloft;A. Darling;E. Watson;B. Flehmig;S. Lawson;G. Frosner
9. Pharmacotherapy v.16 Viral infectivity of albumin and plasma protein fraction Erstad, B. L.
10. Bundesanzeiger v.84 Notice on the registration of drugs: requirements for validation studies to demomstrate the virus safety of drugs derived from human blood or plasma Federal Health Office;Paul Ehrlich Institute Federal Office for Sera and Vaccines
11. Vox Sang. v.67 no.SUP. 1 Removal and inactivation of hepatitis a Virus(HAV) during processing of factor Ⅷ concentrates Hamman, J.;J. Zou;B. Horowitz
12. Curr. Stud. Hematol. Blood Transfus v.56 Strategies to produce virus-safe blood derivatives Heimburger, N.;H. E. Karges
13. Dev. Bio. Stand v.81 Theroretical and technical concerns in inactivation/elimination of viruses in plasma derivatives Hilfenhause, J.;M. Niedrig;T. Nowak
14. Dev. Biol. Stand v.75 Introductory remark: viral safety of biologicals Horaud, F.
15. Yale J. Med v.63 Blood protein derivative viral safety: observations and analysis Horowitz, B.
16. Vox Sang. v.74 no.SUP. 1 Virus inactivation by solvent/detergent treatment and the manufacture of SD-plasma Horowitz, B.;A. Lazo;H. Grossberg;G. Page;A. Lippin;G. Swan
17. Lancet v.2 Virus safety of solvent/detergent treated antihaemophiliac factor concentrates Horowitz, M. S.;C. Rooks;B. Horowitz;M. W. Hilgartner
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20. J. Microbiol. Biotechnol v.10 Partitioning and inactivation of viruses by cold ethanol fractionation and pasteurization during manufacture of albumin from human plasma Kim, I. S.;H. G. Eo;C. E. Chang;S. Lee
21. Biotechnol. Bioprocess Eng. v.6 Removal and inactivation of human immunodeficiency virus(HIV-1) by cold ethanol fractionation and pasteurization during the manufacturing of albumin and immunoglobulins from human plasma Kim, I. S.;H. G. Eo;C. W. Park;C. E. Chang;S. Lee
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26. Dev. Biol. Stand v.102 Residual risk of transfusion transmitted viral infections among seronegative donors: application of the incidence/window period model Kleinman, S.
27. Virology(3rd ed.) Levy, J. A.;H. Fraenkel-Conrat;R. A. Owens
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31. Dev. Biol. Stand v.81 Criteria for the choice of viruses in validation studies Minor, P. D.
32. Beitr. Infusionsther v.24 Inactivation of viruses and safety of stable plasma products Morgenthaler, J. J.
33. Transfusion v.39 Foundling viruses and transfusion medicine Mosley, J. W.;J. Rakela
34. Dev. Biol. Stand v.81 Inactivation of HIV, HBV, HCV related viruses and other viruses in human plasma derivatives by pasteurization Nowak, T.;M. Niedrig;D. Bernhardt;J. Hilfenhaus
35. Transfusion v.36 Virus inactivation by pepsin treatment at pH 4 of IgG solutions: tactors affecting the rate of virus inactivation Omar, A.;C. Kempf;A. Immelmann;M. Rentsch;J. J. Morgenthaler
36. Biologicals v.24 The use of a microporous polyvinylidene fluoride(PVDF) membrane filter to separate contaminating viral particles from biologically important proteins Oshima, K. H.;T. T. Evans-strickfaden;A. K. Highsmith;E. W. Ades
37. Dev. Biol. Stand v.88 Safety of biopharmaceuticals: a current perspective Parkman, P. D.
38. Lancet v.1 Sterilization of hepatitis and HTLV Ⅲ viruses by exposure to Tri-n-Butyl phosphate and sodium cholate Prince, A. M.;B. Horowitz;B. Brotman
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41. Curr. Stud. Hematol. Blood Transf. v.56 Overview of viruses relevant to blood transfusion Schilt, U.
42. Dev. Biol. Stand v.81 The significance of the blood-borne viruses: blood banking and transfusion medicine Sherwood, W. C.
43. Intervirology v.23 Characteristics and taxonomy of Parvoviridae Siegl, G.;R. C. Bates;K. I. Berns;B. J. Carter;D. C. Kelly;E. Kurstak;P. Tattersall
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45. Transfusion v.35 Hepatitis C virus infection in hypogammaglobulinemic patients receiving long-term replacement therapy with intravenous immunoglobulin Taliani, G.;E. Guerra;R. Rosso;M. C. Badolato;G. Luzi;G. Sacco;R. Lecce;C. De Bac;F. Aiuti
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47. Note for guidance on plasma derived medicinal products(CPMP/BWP/269/95 rev2) The European Agency for the Evaluation of Medicinal Products: Human Medicines Evaluation Unit.;Committee for Proprietary Medicinal Products(CPMP)
48. Note for guidance on quality of biotechnology products: viral safety evaluation of biotechnology products derived from cell Lines of human or animal origin(CPMP/ICH/295/95) The European Agency for the Evaluation of Medicinal Products: Human Medicines Evaluation Unit.;Committee for Proprietary Medicinal Products(CPMP)
49. Dev. Biol. Stand v.88 Process scale considerations in evaluation studies and scale-up Walter, J. K.;W. Werz;W. Berthold
50. Dev. Biol. Stand v.81 Theoretical considerations on viral inactivation or elimination Willkommen, H.;J. Lower