In Vivo Metabolism Overview
In vivo metabolism studies are critical to the development of compounds. Select from flexible metabolism studies and services, ranging from high throughput PK screening of compound libraries through definitive dose linearity and escalation/tolerability ahead of safety assessment or your IND/CTA filing.
We also offer formulation bridging studies, experience with bioequivalence and biosimilars, as well as radiolabel distribution, excretion and metabolite identification.
In addition to offering a full suite of in vivo metabolism studies required to answer regulatory questions, we provide assistance with regulatory consutling or writing assistance for regulatory documentation.
Many sponsors also work closely with us to gain advice on which investigative studies to select or which studies would best target mechanistic insights for their compounds.