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
Using 14C radiolabeled clinical studies to explore and evaluate factors influencing oral exposure - ISSX 2017
This poster describes a 2 part study combing an IV microtracer study with a conventional oral ADME study
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.