1. Improved analytical recovery by taking into account sample matrix and chromatographic instrumentation;Li J.;American Pharmaceutical Review,2012
2. FDA Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics July2015.
3. ICH Q2 Validation of Analytical Procedures: Text and Methodology.
4. EMA Guideline on Bioanalytical Method Validation February2012.
5. WHO Guidelines on Validation – Appendix 4 Analytical Method Validation June2016.