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A drug's life
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A revision of the validation guideline ICH Q2(R1) is planned
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About small values with huge influence - Sum Of Squares - part 1
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About small values with huge influence - Sum Of Squares - part 2
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Analytical versus bioanalytical method validation
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Bioanalytical method validation
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Calculation template for the evaluation of precision during method validations
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Determination of trueness and precision at the limit of quantitation (LOQ)
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How to determine the LOD using the calibration curve?
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Increasing the sensitivity in case of LOD / LOQ problems in HPLC methods
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Inferring trueness from linearity – 1. Approach: Normalization
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Inferring trueness from linearity – 2. Approach: Recovery
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Intermediate precision
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Journal Club: Validation of a cIEF method for antibody identification
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Journal Club: Validation of a clot lysis assay for potency
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Journal Club: Validation of a photometric method for content determination
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Journal Club: Validation of a thin layer chromatography (TLC) method for content determination
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Journal Club: Validation of LSV and RP-HPLC to determine content and purity
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Journal Club: Validation of Raman spectroscopy for content determination in tablets
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Limit tests - (when) do they play a role?
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Linear versus non-linear regression: What should be considered?
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Linearity tests
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LOD: What’s behind the "3.3" or: the underlying statistics
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Lots of sensitivities, or: How do analytical, diagnostical, and functional sensitivity differ?
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Method categories according to the ICH Q2(R1)
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New potency assays for anti-VEGF antibodies
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Outliers in method validation and transfer
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Risk assessments in method validation
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Stability-indicating methods and their role in drug’s quality control
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Template for calculating the trueness in method validations
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Template for linearity calculations of method validations
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Template method validation plan all tests
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Template method validation plan assay
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Template method validation plan identification test
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Template method validation plan impurity tests
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The confidence interval in method validation
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The validation report - content, structure and design tips
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Using the relative response for method validations and routine measurements
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Validation of microbiological methods
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What are system suitability tests (SST) of analytical methods?
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What does the ZLG Aide mémoire 07123101 "Inspection of analytical validation and method transfer" actually tell us?
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What is a confidence interval?
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What is a validation plan and what does it tell us?
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What is linearity?
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What is meant by the limit of detection and quantification (LOD / LOQ)?
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What is precision?
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What is robustness?
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What is the difference between specificity and selectivity?
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What is the ICH Q2(R1) guideline?
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What is the range of an analytical method?
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What is trueness?
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What's the difference between method qualification and method validation?
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What’s the difference between method verification and method validation?
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What’s the meaning of "dilution integrity", "dilution linearity" and "parallelism"?
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Which analytical methods must be validated?