1. ICH Q2R1, Validation of Analytical Procedures. Harmonised Tripartite Guideline:1-13,2005
2. Managing the analytical lifecycle for biotechnology products: a journey from method development to validation, part 1;Apostol;Bioprocess Int,2008
3. Managing the analytical lifecycle for biotechnology products: a journey from method development to validation, part 2;Apostol;Bioprocess Int,2008
4. Analytical method validation for biopharmaceuticals;Apostol,2012
5. Chromatography Section, <621>,2017