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What is 07 Validating Potency Assays about?

The document discusses the evolving approaches to validating potency assays, highlighting the contrast between the traditional ICH Q2 (R1) method and the newer USP <1033> Biological Assay Validation. While ICH Q2 provides a common framework for assay characteristics, the USP approach allows for fewer assay runs to determine accuracy and precision, which can significantly reduce validation time. An industry survey indicates a shift towards a mixed validation strategy that incorporates elements from both meth

Author

Harry Patel

Language

EN