Bioanalytical method validation guidance language and a decade of progress

Want to stay updated with the latest news and gain exclusive access to Bioanalysis journal articles? Become a member for free. Keywords: BMV, harmonization, regulations Over the last 10 years, bioanalytical method validation (BMV) has evolved in terms of science and health authority guideline language. Bioanalysts in 2019 need to be cognizant of a multitude of guidance and the associated interpretations around the globe. The transgression from a single regulatory document in effect in 2009, to today’s status has been documented through many publications in Bioanalysis. As such, this reflection paper recalls some of the pivotal points that have impacted...