참고문헌
- Biotechnol. Appl. Biochem v.28 Chromatographic removal and heat inactivation of hepatitis A virus during the manufacture of h Adcock W.L.;A MacGregor;J.R. Davies;M. Hattarki;D.A. Anderson;N.H. Goss
- Biotechnol. Appl. Biochem v.28 Chromatographic removal and heat inactivation of hepatitis B virus during the manufacture of human albumin Adcock W.L.;A. MacGregor;J.R. Davies;M. Hattarki;D.A. Anderson;N.H. Goss
- Thromb. Haemost v.67 Treatment of hemophilia A with a highly purified factor VIII concentrate prepared by Anti-FVIIIc immunonaffinity chro-matography Addiego Jr J.E.;E. Gomperts;S. Liu;P. Bailey;S.G. Courter;M.L. Lee;G.G. Neslund;H.S. Kingdon;M.J. Griffith
- Dev. Biol. Stand v.81 Chromatographic removal of viruses from plasma derivatives Burnouf T.
- J. Chromatogr B v.664 Chromatography in plasma fractionation;benefits and future trends Burnouf T.
- Vox. Sang v.60 A highly purified factor VIII;c concentrate pre-pared from cryoprecipitate by ion-exchange chromatography Burnouf T.;M. Burnouf-radosevich;J.J. Huart;M. Gou-demand
- Downstream thirty one Evolution of coagulation factor concentrates;biotechnological breakthrough of immunoaffinity chromatography using monoclonal anti-bodies Chandra S.;C.C. Huang;F. Feldman;J. Berglof(ed.)
- Bundesazeiger v.84 Notice on the registration of drugs;requirements for validation studies to demonstrate the virus safety of drugs derived from human blood or plasma Federal Health Office and Paul Ehrlich Institute Federal Office for Sera and Vaccines
- Biotechnology and the promise of pure factor VIII Hemofil M;characteristics, pharmaco-kinetics, efficacy and safety Gomperts E.
- Yale J. Med v.63 Blood protein derivative viral safety;obser-vations and Analysis Horowitz B.
- Vox Sang v.74 no.Suppl. 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
- Dev. Biol. Stand v.81 Viral safety of solvent-detergent treated blood products. Horowitz B.;A.M. Prince;M.S. Horowitz;C. Watklevicz
- Lancet v.2 Virus safety of solvent/detergent treated antihaemophil-iac factor concentrates Horowitz M.S.;C. Rooks;B. Horowitz;M.W. Hilgartner
- J. Med v.330 Hemophilia A.N. Engl Hoyer L.W.
- Federal Resister v.63 no.185 Guidance on viral safety evaluation of biotchnology products derived from cell lines of human or animal origin;availability International Conference on Harmonisation
- Arch. Exp. Path. Pharmak v.162 Beitrag zur kollectiven Behandlung pharma-kologische Reihenversuche Karber J.
- Dev. Biol. Stand v.81 Affinity chromatography to remove viruses during preparation of plasma derivatives Lawrence J.E.
- Vox Sang v.64 Clinical evaluation of viral safety of coagulation factor VIII and IX concertrates Mannucci P.M.
- Transfusion v.39 Foundling viruses and trans-fusion medicine Mosley J.W.;J. Rakela
- 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. Berhardt;J. Hilfenhause
- 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
- Curr. Stud. Hematol. Blood. Transfus v.56 Removal of viral contaminants by monoclonal antibody purification of plasma proteins Schreiber A.B.;M.E. Hrinda;J. Newman;G.C. Tarr;R. DAl-isa;W.M. Curry
- Note for guidance on virus validation studies;the design, contribution and inter-pretation of studies validating the inactivation and removal of viruses (CPMP/BWP/268/95) Human Medicines Evaluation Unit. Committee for Pro-prietary Medicinal Products(CPMP) The European Agency for Evaluation of Medicinal Prod-ucts
- Note for guidance on plasma derived medicinal products(CPMP/BWP/269/95 rev2) Human Medicines Evaluation Unit. Committee for Pro-prietary Medicinal Products (CPMP) The European Agency for the Evaluation of Medicinal Products
- 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) Human Medicines Evaluation Unit. Committee for Pro-prietary Medicinal Products(CPMP) The European Agency for the Evaluation of Medicinal Prod-ucts