If your drug is approaching the end of Phase II clinical development or you are planning for your regulatory submission, Quotient Sciences can help you meet your program goals. With many years’ experience as a leading provider of human ADME 14C radiolabeled studies, we have the scientific expertise and operational know-how to design and deliver human ADME programs in preparation for NDA, MAA and global regulatory filings.
Our Synthesis-to-Clinic® support – from radiosynthesis 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.
“We conducted a 14C human AME study with Quotient…. We were extremely satisfied with all aspects of the study, including project management, formulation development, manufacture, clinical conduct and reporting. We would use Quotient again for this type of study.”
Oliver Schueller, SVP CMC and Clinical Pharmacology, Kadmon.