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Course introduction
1. Validation: General
1.1. The purpose of validation
1.2 Carrying out validation
1.3. Scope of validation
1.4. ValChrom
1.5. Uploading data in ValChrom
1.6. Comparison of validation guidelines
Self test 1
2. Selectivity and identity confirmation
2.1. Selectivity: LC selectivity
Self test 2.1
2.2. Selectivity: detector-side (MS) selectivity
Self test 2.2
2.3. Selectivity examples
2.4. Introduction to identity confirmation
Self test 2.4
2.5. Identity confirmation: retention time
2.6. Identity confirmation by MS
2.7. Identity confirmation examples
Self test 2.7
3. Linearity of signal, linear range, sensitivity
3.1. Linearity
Self-test 3.1
3.2. Experiment setup and evaluation of the data
Self test 3.2
3.3. Estimating the linear range
Self-test 3.3
3.4. Sensitivity
Self test 3.4
4. Precision
4.1. Repeatability, intermediate precision and reproducibility
4.2. Calculation of precision
4.3. Acceptance criteria
4.4. Examples
Self test 4.4A
Self test 4.4B
Self test 4.4C
Self test 4.4D
5. Trueness
5.1 Bias and its constituents
5.2 Determining bias in practice
Self test 5.2A
Self test 5.2B
5.3 Qualitative estimation of matrix effect
5.4 Quantitative estimation of matrix effect, recovery and process efficiency
Self-test 5.4A
Self-test 5.4B
Self-test 5.4C
6. Precision and trueness: some additional aspects
6.1. Choosing sample type, concentration levels, replicates and time range for precision
Self test 6.1
6.2. Obtaining reference value for bias calculation
Self test 6.2
6.3 Avoiding/minimizing bias and correcting for bias
Self test 6.3
6.4. Real life examples
Self test 6.4
7. Accuracy
Self test 7
8. Stability
8.1 Different types of stability
Self test 8.1
8.2 Examples of unstable analytes
8.3 Evaluation of stability
Self test 8.3
8.4 Aspects to be considered if analytes are unstable
9. LoD and LoQ
9.1. Definitions and important aspects
Self test 9.1
9.2. Decision limit and Detection capability
Self test 9.2
9.3. Estimation of LoD
Self test 9.3
9.4. Estimation of LoQ
Self test 9.4
Bonus self test 9.5
10. Ruggedness, robustness
Self test 10
10.1 Robustness and ruggedness relation to LC-MS method development
Self test 10.1
10.2 Matrix robustness
Self test 10.2
10.3 Different ways to evaluate robustness
Self test 10.3
10.4 Experimental design
Self test 10.4
10.5 Bonus section: DoE introduction for beginners
Acknowledgements
Questions and answers about precision, trueness and accuracy topics
References
Glossary
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Validation of liquid chromatography mass spectrometry (LC-MS) methods
4.4. Examples
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Example for calculating
repeatability
https://www.uttv.ee/naita?id=32142
https://youtu.be/4eKvvgNOH3c
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Example for calculating
intermediate precision
http://www.uttv.ee/naita?id=24825
https://www.youtube.com/watch?v=97oc1HpgnEM
precision_blank.xlsx
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Course introduction
1. Validation: General
1.1. The purpose of validation
1.2 Carrying out validation
1.3. Scope of validation
1.4. ValChrom
1.5. Uploading data in ValChrom
1.6. Comparison of validation guidelines
Self test 1
2. Selectivity and identity confirmation
2.1. Selectivity: LC selectivity
Self test 2.1
2.2. Selectivity: detector-side (MS) selectivity
Self test 2.2
2.3. Selectivity examples
2.4. Introduction to identity confirmation
Self test 2.4
2.5. Identity confirmation: retention time
2.6. Identity confirmation by MS
2.7. Identity confirmation examples
Self test 2.7
3. Linearity of signal, linear range, sensitivity
3.1. Linearity
Self-test 3.1
3.2. Experiment setup and evaluation of the data
Self test 3.2
3.3. Estimating the linear range
Self-test 3.3
3.4. Sensitivity
Self test 3.4
4. Precision
4.1. Repeatability, intermediate precision and reproducibility
4.2. Calculation of precision
4.3. Acceptance criteria
4.4. Examples
Self test 4.4A
Self test 4.4B
Self test 4.4C
Self test 4.4D
5. Trueness
5.1 Bias and its constituents
5.2 Determining bias in practice
Self test 5.2A
Self test 5.2B
5.3 Qualitative estimation of matrix effect
5.4 Quantitative estimation of matrix effect, recovery and process efficiency
Self-test 5.4A
Self-test 5.4B
Self-test 5.4C
6. Precision and trueness: some additional aspects
6.1. Choosing sample type, concentration levels, replicates and time range for precision
Self test 6.1
6.2. Obtaining reference value for bias calculation
Self test 6.2
6.3 Avoiding/minimizing bias and correcting for bias
Self test 6.3
6.4. Real life examples
Self test 6.4
7. Accuracy
Self test 7
8. Stability
8.1 Different types of stability
Self test 8.1
8.2 Examples of unstable analytes
8.3 Evaluation of stability
Self test 8.3
8.4 Aspects to be considered if analytes are unstable
9. LoD and LoQ
9.1. Definitions and important aspects
Self test 9.1
9.2. Decision limit and Detection capability
Self test 9.2
9.3. Estimation of LoD
Self test 9.3
9.4. Estimation of LoQ
Self test 9.4
Bonus self test 9.5
10. Ruggedness, robustness
Self test 10
10.1 Robustness and ruggedness relation to LC-MS method development
Self test 10.1
10.2 Matrix robustness
Self test 10.2
10.3 Different ways to evaluate robustness
Self test 10.3
10.4 Experimental design
Self test 10.4
10.5 Bonus section: DoE introduction for beginners
Acknowledgements
Questions and answers about precision, trueness and accuracy topics
References
Glossary
What our participants say?
Search
Search
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