Integrated Clinical Development Services
A critical step in clinical development is the human ADME study. Metabolite profiling and structural identification of human metabolites is often challenging, but Pharmaron has extensive experience in helping our partners meet their objectives for these studies. When the 14C dose and/or exposure levels are extremely low, this adds another level of complexity due to sensitivity issues. However, Pharmaron’s integrated services provide a solution.
With seamless transfer of methods between sites, quantitative metabolite profiling of low level samples (usually plasma) can be performed by Accelerator Mass Spectrometry (AMS). Then, structure elucidation can be performed by our metabolite identification group. For example, we recently helped Celgene-Receptos achieve their metabolite profiling/identification objectives for their 14C human metabolism study.
Written with permission by Celgene-Receptos.
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