Last week I attended the AAPS/FDA organized workshop dedicated to biomarker bioanalytical assays. Also known as the Crystal City VI (CCVI) meeting in reference to the original bioanalytical method validation (BMV) series of workshops that have helped establish regulatory practice … [Read more...]
Top-10 Takeaways from Crystal City VI Workshop
The Crystal City VI Workshop was indeed a wealth of information on current perspectives of how we should develop, validate and apply bioanalytical methods for the measurement of endogenous biomarkers. Good input came from drug development bioanalytical scientists, clinical … [Read more...]