As well as supporting early clinical and exploratory studies, Xceleron provides essential absolute bioavailability and mass balance data for late-stage studies. Our data support regulatory submissions to the EMEA and FDA and have contributed to 7 filing packages for marketed drugs.
[pullquote]“The AMS technique provided us with the means to complete our regulatory submission which could never have been done with conventional means. The results were excellent and PhotoCure is delighted to endorse AMS technology as a powerful analytical technique in clinical development”.
Dr Kjetil Hestdal, CEO and President, PhotoCure. [/pullquote]
We have established specialized validation packages to support the bioanalytical requirements of late-stage studies, an important consideration when the study is being used for regulatory submission.
Read about our human ADME/mass balance evaluations in Phase II/III.
Learn more about our IVPK studies in Phase II/III.
Microdosing studies: a consideration on analytical technology choice
"...AMS [is] an invaluable tool in our early drug development program, allowing us to quickly assess bioavailability in humans and focus resources on our most promising drug candidates going forward."
Find out how we can help you accelerate your drug-development program.