Today, drug developers can identify molecules with the most potential early—and avoid unwelcome surprises later—by incorporating FDA- and EMEA-endorsed Phase 0 microdosing studies into development programs. This approach utilizes sub-nanogram amounts of radiolabeled material to track the metabolic pathways and effects of a compound in the human body. It can provide human PK and bioavailability data earlier than the traditional drug development process, saving time and money that is all too often lost when a drug candidate fails in larger, more costly clinical trials.
ABC's unique combination of DMPK expertise and in-house CGMP radiolabeling capabilities promotes collaboration and understanding of your compound's structure and pharmacodynamics across the development team—resulting in faster turnaround and more reliable data. Contact us to learn more about how ABC Laboratories can help you benefit from this exciting approach to early drug development.