Towards harmonized regulations for bioanalysis: moving forward!

“Looking at the current initiatives, the bioanalytical community is motivated to make 2010 the year in which we set the stage for a global bioanalytical guideline.” It is a little over 1 year since the European Medicines Agency (EMA) committee for medicinal products for human use (CHMP) efficacy working party (EWP) released a concept paper on the need for a guideline on bioanalytical method validation (BMV) [101]. Until then, the US FDA guidance on bioanalytical method validation [102] was the only regulatory document fully dedicated to bioanalysis that existed. Although this FDA guideline has been recognized by the bioanalytical community...