Similarity assessment of quality attributes of biological medicines: the calculation of operating characteristics to compare different statistical approaches
Abstract The comparison of quality attributes is a key element in the evaluation of both biosimilars and manufacturing process changes for biological medicines. Different statistical approaches are proposed to facilitate such evaluations. However, there is no regulatory consensus on a quantitative a...
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| Main Authors: | , |
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| Format: | Book |
| Published: |
SpringerOpen,
2019-09-01T00:00:00Z.
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| Online Access: | Connect to this object online. |
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Internet
Connect to this object online.3rd Floor Main Library
| Call Number: |
A1234.567 |
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| Copy 1 | Available |