Building the Global Bioanalysis Consortium – working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation

“...it was decided to set-up an all-inclusive Global Bioanalysis Consortium consisting of scientific associations with worldwide recognition and influence in order to create one unified document that, after thorough discussion in global conferences, can be presented to the decision makers in each country or region.” Although harmonization of bioanalytical method validation (BMV) and application has been discussed at scientific forums on several occasions, it was not until the European Bioanalysis Forum (EBF) conference in December 2009 [1], where the European Medicines Agency’s (EMA) intended draft bioanalytical method validation guideline [101] was discussed, that the bioanalytical scientists present expressed their strong...