Concentrate safety and efficacy.
Safety from transmission of infections through plasma-derived clotting factor concentrates is assured by improved donor screening, serological testing of individual donations and direct viral testing of small plasma pools. Modern viral-inactivation techniques are highly effective. Recombinant concentrates stabilized in human albumin are being superaeded by those with other stabilizers. Recently reported discrepancies between estimates of concentrate potency from in vitro assays versus in vivo recovery, depending upon type of assay and reference standard used, are not fully resolved.
Kasper
C K
CK
Orthopaedic Hospital, 2400 South Flower Street, Los Angeles, CA 90007, USA. ckasper@laoh.ucla.edu
D005164:Factor IX / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D005169:Factor VIII / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D006467:Hemophilia A / Q000188:drug therapy*; D006801:Humans; D013810:Therapeutic Equivalency; D014777:Virus Diseases / Q000517:prevention & control / Q000635:transmission
D005169:Factor VIII; D005164:Factor IX