Transcription of Assay Qualification/Validation – a Reviewer’s …
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Assay Qualification/Validation – a Reviewer’s …
1 Assay Qualification/Validation a Reviewer s ExpectationsSarah KennettDivision of Monoclonal AntibodiesOffice of Biotechnology ProductsOPS/CDER/FDAO ctober 20, 20102 DisclaimerThe views and opinions expressed here are my own and should not be used in place of regulations, published FDA guidances or discussions with the views reflect CDER/OPS/OBP talk is focused on analytical assays used to assess drug substance, drug product, and in-process this subject?What does FDA say officially?What do we OBP product reviewers mean by qualification and validation ?Some expectations4 Person X: Someone told me assays need to be validated to start Phase 2 studies.
3 Overview Why this subject? What does FDA say – officially? What do we OBP product reviewers mean by “qualification” and “validation”? Some expectations
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