FDA approach to evaluation of pathogen reduction technology

[1] Evaluation of an automated culture system for detecting bacterial contamination of platelets: an analysis with 15 contaminating organisms [J]. TRANSFUSION, 2001, 41 (04) : 477 - 482

[2] BRECHER ME, 2003, BLOOD THERAPIES MED, V2, P49

[3] Current and emerging infectious risks of blood transfusions [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2003, 289 (08): : 959 - 962

[4] Bacterial contamination and transfusion safety: experience in the United States [J]. TRANSFUSION CLINIQUE ET BIOLOGIQUE, 2003, 10 (01) : 6 - 9

[5] *FDA, 1999, WORKSH BACT CONT PLA

[6] *FDA, 2002, WORKSH SAF EFF METH

[7] FDA, 2002, CARC STUD PROT SUBM

[8] *FDA, 1998, WORKSH EV IN VIV EFF

[9] *FDA, 1997, SBI TEST CARC PHARM

[10] *FDA, 1999, FDA DRAFT GUID PLAT

[1] Evaluation of an automated culture system for detecting bacterial contamination of platelets: an analysis with 15 contaminating organisms [J]. TRANSFUSION, 2001, 41 (04) : 477 - 482

[2] BRECHER ME, 2003, BLOOD THERAPIES MED, V2, P49

[3] Current and emerging infectious risks of blood transfusions [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2003, 289 (08): : 959 - 962

[4] Bacterial contamination and transfusion safety: experience in the United States [J]. TRANSFUSION CLINIQUE ET BIOLOGIQUE, 2003, 10 (01) : 6 - 9

[5] *FDA, 1999, WORKSH BACT CONT PLA

[6] *FDA, 2002, WORKSH SAF EFF METH

[7] FDA, 2002, CARC STUD PROT SUBM

[8] *FDA, 1998, WORKSH EV IN VIV EFF

[9] *FDA, 1997, SBI TEST CARC PHARM

[10] *FDA, 1999, FDA DRAFT GUID PLAT