Human ADME
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.
Quotient Sciences' Synthesis-to-Clinic® approach pulls all the necessary elements required for the completion of a human ADME program together into a single, integrated program of work. We drive 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.
Download our latest whitepaper
Learn more about our expertise and capabilities in our whitepaper, Synthesis to Clinic: A streamlined approach to 14C human ADME studies.
What Our Clients Say
“We conducted a 14C human ADME 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 at Kadmon, a Sanofi Company
Get to know our experts
Iain Shaw is Senior Director of 14C Enabled Drug Development at Quotient Sciences. Iain has over 30 years of experience in the pharmaceutical industry, including more than 20 years of drug development experience and extensive experience with 14C human ADME studies.
Learn more about our capabilities
Our team of experts have extensive chemical and radiochemical knowledge and experience of isotopically labeling hundreds of molecular entities.
Resources
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WhitepaperSynthesis to Clinic: A streamlined approach to 14C human ADME studiesWe are a leading provider of 14C-enabled drug development programs, successfully conducting over 350 human ADME and other radiolabeled programs to date. Learn about Synthesis-to-Clinic®.
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Scientific PostersA Decade of Human ADME at Quotient Sciences: Reviewing Key Study Design Variables and OutcomesA Decade of Human ADME at Quotient Sciences: Reviewing Key Study Design Variables and Outcomes.
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WebinarStreamlining the Delivery of 14C Human ADME Data: An ADME Q&A RoundtableExperts from Quotient Sciences and The Netherlands Organization for Applied Scientific Research (TNO) discuss streamlining human ADME studies.
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Info SheetHuman ADME CapabilitiesWith over 30 years’ experience as a world 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.