1. Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.
2. Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report)
3. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, 2005.
4. EP21-A, Estimation of total analytical error for clinical laboratory methods; Approved Guideline, Clinical and Laboratory Standards Institute, CLSI 21-A, Wayne, PA, 2003.
5. ISO/CEI 17025: General Requirements for the Competence of Testing and Calibration Laboratories, International Organization for Standardization (ISO), Geneva, 2005.