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 in English 6-2-6-2-6 replicates (Excel, Feb. 2011 updated version)

  4. Spreadsheet in English 3-3-3-3-3 replicates (Excel, Feb. 2011 updated version)

  5. Link to ICH Q2 guideline

  6. Link to FDA announcement

  7. Calibration Background

  8. Coming Soon: Extension of strategy and spreadsheets to non-linear (second order) Calibration curves

Comments, changes and updates.
110209. Spreadsheets: Intermediate reproducibility added (3 levels, 3 days)

110221. Spreadsheets: added a check to see whether control of calibration data i supplied.



2. Bioanalysis

  1. Link to FDA guideline for Bioanalysis (link date, 110810

  2. EMA guideline (valid from Feb. 2012, link date 110810)

  3. Validation of Bioanalytical methods, pharmaceutical research 8, 1991, 421-426 (link date 150608)

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



clco 25/6-2015