The FDA's "Center for Drug Evaluation and Research (CDER)" has initiated a research collaboration with Abreos Biosciences to develop methods to measure biological drug concentrations in blood with high sensitivity and specificity. Abreo's platform Veritope ™ has the advantage of being able to quickly produce reagents that can be adapted to different analysis platforms, including clinical trials.
The goal of the FDA CDER and Abreo's joint development work is to evaluate new methods for measuring biological components where the FDA is particularly interested in methods that can be developed and validated quickly for regulatory purposes. The FDA has also identified a need in studies to characterize drug kinetics and efficacy. Being able to determine the concentration of biological drugs can result in safer and more efficient use of drugs in human medicine.