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As a leading provider of human ADME 14C radiolabeled studies, Quotient Sciences has the scientific expertise and operational know-how to design and deliver human ADME programs in preparation for New Drug Application (NDA), Marketing Authorization Application (MAA), and global regulatory filings.
Whether you're approaching the end of Phase II clinical development or planning for your regulatory submission, we can help you simplify the delivery of your human ADME studies. Learn more about our expertise and capabilities in our latest whitepaper, Synthesis to Clinic: A streamlined approach to 14C human ADME studies.
Our Synthesis-to-Clinic® support – from radiosynthesis (isotopically labelled (14C/SIL)) to final clinical report – pulls all the necessary elements required for the completion of a human ADME program together into a single, integrated program of work.
Learn more about our approach to conducting human ADME studies by contacting our experts now.
“We conducted a 14C human AME study with Quotient Sciences… We were extremely satisfied with all aspects of the study, including project management, formulation development, manufacture, clinical conduct, and reporting. We would use Quotient Sciences again for this type of study.”
Oliver Schueller, SVP CMC and Clinical Pharmacology, Kadmon