Documents related to how we validate analytical methods in the DMAT-group
1. Drug Analysis

  1. Validation strategy  in Danish (PDF)

  2. Validation strategy  in English (PDF)

  3. Spreadsheet, linear calibration in English 5 levels, 3 replicates (Excel, April. 2020 updated version)

  4. Spreadsheet linear calibration, in English 6 levels 6 replicates (Excel, April. 2020, updated version )

  5. Spreadsheet linear calibration, in English 7 levels 3 replicates (Excel, April. 2020, updated version )

  6. Spreadsheet linear calibration, in English 7 levels 6 replicates (Excel, April. 2020, updated version )

  7. Spreadsheet linear calibration, in English 8 levels 6 replicates (Excel, April. 2020, updated version )

  8. Spreadsheet linear calibration, in English 8 levels 9 replicates (Excel, April. 2020, updated version )

  9. Link to ICH Q2 guideline

  10. Link to FDA announcement

  11. Calibration Background

  12. Link to FDA, analytical Quality by design



2. Bioanalysis

  1. Link to FDA guideline for Bioanalysis (link date, 190906

  2. EMA guideline (valid from Feb. 2012, link date 190906)

  3. ICH M10 guideline, draft version 2019 (190906)

  4. Validation of Bioanalytical methods, pharmaceutical research 8, 1991, 421-426 (link date 190906)

  5. Harmonised Guidelines for the Use of Recovery Information in Analytical Measurement, Pure Appl. Chem., 71, 1999, 337 – 348. (link date 150608)



Clco 2/3-2020