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.
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 project manager
Application Of Non Standard Approaches To Investigations Of Human Mass Balance And Metabolite Characterisation
Conventional 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.
14C Microtracer approaches to inform formulation development strategies in early clinical drug development - AAPS 2016
This poster describes how combining an intravenous (IV) microtracer regimen with an oral tracer regimen, can generate key pharmacokinetic (PK) parameters.
Conduct of clinical ADME study for Vosaroxin in oncology patients - AAPS 2015
Conduct of clinical ADME study for Vosaroxin in oncology patients via real-time adaptive manufacture of intravenous drug product.
Human ADME studies
With 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.