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European Multicenter Study on Analytical Performance of DxN Veris System HCV Assay

Patrick Braun1, Rafael Delgado2, Monica Drago3

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Journal of Clinical Microbiology
|February 3, 2017
PubMed

Keywords:
HCVanalytical performanceautomatedquantitation

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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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