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. 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.
3. ISO 5725, Application of the Statistics-Accuracy (Trueness and Precision) of the Results and Methods of Measurement—Parts 1 to 6, International Organization for Standardization (ISO), Geneva, 1994.