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  • A drug's life

  • A revision of the validation guideline ICH Q2(R1) is planned

  • About small values with huge influence - Sum Of Squares - part 1

  • About small values with huge influence - Sum Of Squares - part 2

  • Analytical versus bioanalytical method validation

  • Bioanalytical method validation

  • Calculation template for the evaluation of precision during method validations

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

  • How to determine the LOD using the calibration curve?

  • Increasing the sensitivity in case of LOD / LOQ problems in HPLC methods

  • Inferring trueness from linearity – 1. Approach: Normalization

  • Inferring trueness from linearity – 2. Approach: Recovery

  • Intermediate precision

  • Journal Club: Validation of a cIEF method for antibody identification

  • Journal Club: Validation of a clot lysis assay for potency

  • Journal Club: Validation of a photometric method for content determination

  • Journal Club: Validation of a thin layer chromatography (TLC) method for content determination

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

  • Journal Club: Validation of Raman spectroscopy for content determination in tablets

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

  • Linear versus non-linear regression: What should be considered?

  • Linearity tests

  • LOD: What’s behind the "3.3" or: the underlying statistics

  • Lots of sensitivities, or: How do analytical, diagnostical, and functional sensitivity differ?

  • Method categories according to the ICH Q2(R1)

  • New potency assays for anti-VEGF antibodies

  • Outliers in method validation and transfer

  • Risk assessments in method validation

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

  • Template for calculating the trueness in method validations

  • Template for linearity calculations of method validations

  • Template method validation plan all tests

  • Template method validation plan assay

  • Template method validation plan identification test

  • Template method validation plan impurity tests

  • The confidence interval in method validation

  • The validation report - content, structure and design tips

  • Using the relative response for method validations and routine measurements

  • Validation of microbiological methods

  • What are system suitability tests (SST) of analytical methods?

  • What does the ZLG Aide mémoire 07123101 "Inspection of analytical validation and method transfer" actually tell us?

  • What is a confidence interval?

  • What is a validation plan and what does it tell us?

  • What is linearity?

  • What is meant by the limit of detection and quantification (LOD / LOQ)?

  • What is precision?

  • What is robustness?

  • What is the difference between specificity and selectivity?

  • What is the ICH Q2(R1) guideline?

  • What is the range of an analytical method?

  • What is trueness?

  • What's the difference between method qualification and method validation?

  • What’s the difference between method verification and method validation?

  • What’s the meaning of "dilution integrity", "dilution linearity" and "parallelism"?

  • Which analytical methods must be validated?

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