Some thoughts on the QR method for analytical similarity evaluation
Some thoughts on the QR method for analytical similarity evaluation
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Publisher
England: Taylor & Francis
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Language
English
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Publisher
England: Taylor & Francis
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Scope and Contents
Contents
As indicated in a recent published draft guidance on comparative analytical assessment, the United States (US) Food and Drug Administration (FDA) seems to suggest the use of quality range (QR) method for analytical similarity evaluation. It is a concern that the use of QR method for analytical similarity evaluation could potentially approve biologi...
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Full title
Some thoughts on the QR method for analytical similarity evaluation
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TN_cdi_pubmed_primary_32089068
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_pubmed_primary_32089068
Other Identifiers
ISSN
1054-3406
E-ISSN
1520-5711
DOI
10.1080/10543406.2020.1726372
