Human ADME

How can I simplify the delivery of my human ADME study?

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 of 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 New Drug Application (NDA), Marketing Authorization Application (MAA), and global regulatory filings.

A nurse taking the blood pressure of a study participant at our clinical testing facility in Miami

Facilitated by Synthesis-to-Clinic® 

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.

  • Drives efficient development and manufacturing of 14C drug products tailored to the specific requirements of your ADME program — including intravenous (IV) products to generate IV pharmacokinetic and absolute bioavailability data, where appropriate
  • Supports your entire ADME program, from radiosynthesis through to clinical reporting, delivering all of these components on your behalf under the guidance of a single Quotient Sciences project manager

Learn more about our approach to conducting human ADME studies in our latest webinar. 

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Enhancing Your Clinical Studies

What Our Clients Say

“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

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