1. International Conference on Harmonization Q2 (R1) Guideline. (2005). Validation of analytical procedures: text and methodology.
2. US Food and Drug Administration. (2000). Center for Drug Evaluation and Research, August, Guidance for industry: Analytical procedures and methods validation, chemistry, manufacturing, and control documentation.
3. Method validation in pharmaceutical analysis: A guide to best practice;Ermer,2005
4. Analytical method development and validation;Swartz,1997
5. US Food Drug Administration. (2006). Center for Drug Evaluation and Research, January, Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies.