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. Learn more about our expertise and capabilities in our latest whitepaper, Synthesis to Clinic: A streamlined approach to 14C human ADME studies.
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.
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
Human ADME
Fact sheets and scientific posters
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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.
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Info SheetIsotope LabellingWhether you need isotopically labelled (14C/SIL) compounds for nonclinical or clinical metabolism studies and the quantification of materials in biological matrices, our expertise provides the necessary labelled materials tailored to support your studies.
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Scientific PostersApplication Of Non Standard Approaches To Investigations Of Human Mass Balance And Metabolite CharacterisationConventional human metabolism studies are well understood study designs which help drug companies generate data to support drug development and registration. Variations from conventional study designs can be required as a result of the specific characteristics of individual drugs or the need for particular data to support drug registration. This poster describes scenarios where alternative study designs and approaches have been required.
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Scientific Posters14C Microtracer approaches to inform formulation development strategies in early clinical drug development - AAPS 2016This poster describes how combining an intravenous (IV) microtracer regimen with an oral tracer regimen, can generate key pharmacokinetic (PK) parameters.