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A pharmacokinetic study of an ion‐exchange solvent—detergent‐treated high‐purity factor VIII concentrate
Author(s) -
Ludlam C. A.,
Lowe G. D. O.,
Mayne E. E.
Publication year - 1995
Publication title -
transfusion medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.471
H-Index - 59
eISSN - 1365-3148
pISSN - 0958-7578
DOI - 10.1111/j.1365-3148.1995.tb00217.x
Subject(s) - pharmacokinetics , solvent , chromatography , chemistry , ion chromatography , crossover study , ion exchange , ion , pharmacology , medicine , organic chemistry , alternative medicine , pathology , placebo
SUMMARY. An ion‐exchange chromatography purified factor VIII concentrate (Liberate) that had undergone a solvent—detergent viral inactivation treatment was compared with an intermediate‐purity concentrate (Z8), which was terminally heated at 80°C for 72 h, in 15 haemophilia A patients in a blinded crossover pharmacokinetic study. Both products achieved a peak level close to that predicted (100IU/dl for Liberate and 103IU/dl for Z8) and there were no significant differences in the recoveries achieved nor of any of the other pharmacokinetic parameters. We conclude that the pharmacokinetic properties of factor VIII: C, following solvent—detergent treatment and ion‐exchange chromatography, are equivalent to those of the lower purity terminally heat‐treated product (Z8), and it is therefore likely to be a clinically efficacious concentrate.