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Assay Reproducibility when Applied to Incurred Samples
Some time has now passed since the AAPS meeting on ‘assay reproducibility for incurred samples’ was held on 7-8th February this year in Crystal City, Arlington, VA. This has given us, and our clients, time to work with the suggestions of the meeting. The meeting provided a great deal of clarity on what the FDA (and the industry) expects to see for investigations of this type and, as a result, we, and many of our sponsors, have adopted new SOPs for such reanalyses.
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