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Updated: May 3, 2026

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使用反应剂/平台特定的转换因子来确定Nonacog Beta Pegol (N9-GP,Refixia®) 活动的不同FIX活动测试的性能评估

Christian Irsara1,2, Andrea Griesmacher1,2,3, Bernhard Strasser2,4

  • 1Central Institute of Medical and Chemical Laboratory Diagnostics (ZIMCL), University Hospital of Innsbruck, Innsbruck, Austria.

Hamostaseologie
|August 29, 2025
PubMed
概括

在血友性B患者中使用凝血试验监测nonacogβ- pegol (N9- GP) 是具有挑战性的. 这项研究表明N9-GP水平可以使用特定的转换因子进行一阶段FIX测试.

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In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
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