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A pharmacokinetic study of an ion‐exchange solvent—detergent‐treated high‐purity factor VIII concentrate

机译:离子交换溶剂—洗涤剂处理的高纯度因子 VIII 浓缩物的药代动力学研究

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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
机译:总结。在一项盲法交叉药代动力学研究中,对 15 名 A 型血友病患者进行了离子交换层析纯化的因子 VIII 浓缩物 (Liberate) 与在 80°C 下最终加热 72 小时的中等纯度浓缩物 (Z8) 进行了比较。两种产品均达到接近预测值的峰值水平(Liberate 为 100IU/dl,Z8 为 103IU/dl),并且所达到的回收率和任何其他药代动力学参数均无显著差异。我们得出的结论是,在溶剂-洗涤剂处理和离子交换色谱法之后,因子 VIII:C 的药代动力学特性与低纯度终末热处理产品 (Z8) 的药代动力学特性相当,因此它可能具有临床有效性

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