Human ADME
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.
Facilitated by Synthesis-to-Clinic®
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.
- 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.
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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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.
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Scientific PostersConduct of clinical ADME study for Vosaroxin in oncology patients - AAPS 2015Conduct of clinical ADME study for Vosaroxin in oncology patients via real-time adaptive manufacture of intravenous drug product.