For establishment and validation of our bioanalytical methods we apply the current international bioanalytical guidelines of ICH, FDA and EMA (see also guidelines to bioanalytical method validation). -   ICH Guideline Q2(R1): Validation of Analytical Procedures, Nov 2005 -   FDA Guideline Bioanalytical Method Validation, May 2018 -   EMA Guideline Bioanalytical Method Validation, Feb 2012