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DESCRIPTION:USP , “Bacterial Endotoxins Test Using Recombinant Reagents” states, “Regulatory authorities may require supplemental data prior to acceptance…An example of supplemental data may include a comparative study of the material tested by techniques described in this chapter and those in 〈85〉.”  The term, “supplemental data” may refer to the use of a statistically robust analysis of test results obtained from a single sample containing assayable levels of endotoxins activity, using both the predicate assay () and the candidate recombinant assay () .\nThis webinar discusses the difference between 50-200% acceptance testing and statistical equivalence.  In addition, using data in the public domain as examples, the speakers will stress the importance of using a split sample containing assayable levels of contaminating or potentially contaminating endotoxins activity as the test article for these studies.\n
DTSTART:20250428T140000
DTEND:20250428T150000
DTSTAMP:20260625T131754Z
LOCATION:Online
PRIORITY:5
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SUMMARY;LANGUAGE=es-es:Tecnowebinars.com - :: Beyond USP <86>:  Supplemental Testing
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UID:0bedcda77fd786e5191285917438554f Tecnowebinars.com
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