Breath biomarkers are just now entering mainstream consideration as selection markers and outcome variables for pharmaceutical clinical trials. This is due to the recent explosion of low-cost, high-sensitivity analytical tools creating opportunities for meaningful breath biomarker investigations among a much broader set of researchers. While several of our blog posts outline these various techniques and tools, none really offer a perspective on “setting the bar” for how well a biomarker should perform to be qualified.
We thought to pass along the comments of FDA experts as they outline the qualification process and considerations; the public-domain videos below explain the perspective of FDA in their own words. While not specific to breath biomarkers, these videos do outline the thought process underlying the FDA requirements which apply to all biomarkers.
We hope you find these to be useful.
Of course, we are glad to speak with you and help in any way we can. Please Contact Us with any questions. If we don’t have the answer, we’ll find someone who does and introduce you.