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Nuthakki VK, et al

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Publisher: Cell Press

[2] However, pursuant to FDA Guidance Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (Jan 2018), 503(a) and 503(b) facilities may still mix, dilute or repackage

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In a number of disease states, diffuse fibrosis can be assessed by quantitative CMR relaxometry, incorporating T 1 mapping with high reproducibility, however it was not possible in the present study to include T 1 mapping sequences