Shaping Global Standards for Bioanalysis

Global Bioanalysis ConsortiumWhen we provide sample concentration data for submission with new drug applications, clients have an expectation that those data will meet regulatory agency expectations for quality, accuracy, and precision. Those expectations have been evolving since the first US consensus AAPS/FDA workshop (Crystal City I) in 1990. Subsequent workshops and the resulting white papers have formed the basis for guidance documents on conducting method validations and sample analysis. These documents are published by regulatory agencies such as the US FDA and the European Medicines Agency. Continue reading