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  • Determination of trueness and precision at the limit of quantitation (LOQ)

  • Inferring trueness from linearity – 1. Approach: Normalization

  • Inferring trueness from linearity – 2. Approach: Recovery

  • Journal Club: RP-UHPLC-MS versus peptide mapping for antibody characterization

  • Journal Club: Validation of LSV and RP-HPLC to determine content and purity

  • Limit tests - (when) do they play a role?

  • Method categories according to the ICH Q2(R1)

  • Stability-indicating methods and their role in drug’s quality control

  • Template method validation plan impurity tests

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