1. Analysis of recent pharmaceutical regulatory documents on analytical method validation
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 parts 1–6, Accuracy (trueness and precision) of measurement methods and results, International Organization for Standardization (ISO), Geneva, 1994.
4. Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001.