2013 ISPAM Mid-Year Mtg Book

3/11/2013

 Stakeholders reach consensus on: ◦ Intended use  ◦ Applicability ◦ Analytical technique ◦ Definitions ◦ Method performance requirements table ◦ System suitability

◦ Reference materials ◦ Validation guidance ◦ Maximum time‐to‐determination

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 Analytical range  Limit of detection  Limit of Quantitation   Repeatability  Recovery  Reproducibility

All parameters have a minimum requirement set by the Working Group

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