1. Q2(R1): validation of analytical procedures: text and methodology, International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH),, 2005, 〈http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html〉.
2. Method Validation in Pharmaceutical Analysis. A Guide to Best Practice,2005
3. United States Pharmacopeia, General Information Chapter <1010> “Analytical Data—Interpretation and Treatment”.
4. United States Pharmacopeia, General Information Chapter <1033> “Biological Assay Validation”.