Human ADME study – resources

We are a world leader in delivering 14C  human ADME programs to the pharmaceutical industry. With over 30 years’ experience, we have the scientific expertise and operational know-how to design and deliver human ADME programs in preparation for NDA/MAA submissions.

We can guide you through each part of the ADME program, from radiosynthesis through to clinical reporting, and deliver any or all of these components on your behalf.

Learn more

Explore our selection of case studies, fact sheets and scientific posters and see how we can help you to save valuable drug development time and reduce investment costs. 

 

Fact sheet

Human ADME fact sheet Human ADME study list Microdose and microtracer information sheet

 

 

Scientific posters

New

ISSX 2016 - A phase I, open-label, 2-part study to establish absolute bioavailability and the ADME of evogliptin in healthy male subjects by a light – label approach

 

ISSX 2016 - Absorption, metabolism and excretion of 14C-gemigliptin, a novel dipeptidyl peptidase 4 inhibitor, in humans

 

Archive

ISSX 2015 - Integrated Human ADME studies: A review of objectives and outcomes of integrated 14C studies ISSX 2015 - An open-label, single dose study designed to assess the metabolism and mass balance recovery for 14C-Eravacycline in healthy male subjects after oral and intravenous dosing

What data can a 14C Clinical study deliver? A decade of innovative, integrated 14C studies

 

An integrated strategy to determine the absorption, distribution, metabolism, excretion, and the absolute bioavailability of Bevenopran (CB-5945) in healthy male subjects Overcoming the Challenges of Working with 14C API and 14C IMP in Clinical Development AAPS 2013 Integrated 14C Study Designs to provide intravenous Pharmacokinetics and Human Mass Balance and Metabolism Data froma Single Protocal and a Single Regulatory Submission EACPT 2013 ADME Study of 14C-netupitant Administered as an oral 300mg suspension to healthy male subjects ESMO 2012 FDA Metabolite Safety Testing Guidelines: The Mist Clears ASCPT 2010

 

 

 

 

Presentations

ISSX 2015 - Enriching human mass balance studies: maximising data output and drug disposition knowledge What data can a 14C clinical study deliver? A decade of innovative, integrated 14C study designs to understand drug behaviour in human subjects Clinical studies utilizing Accelerator Mass Spectrometry: Opportunities and challenges of 14C radiolabelled microtracerstudy delivery Addressing the challenges of working with 14C radiolabelled drug substance and drug product in clinical development through a Translational Pharmaceutics® platform

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