Human ADME

  • Do you have a compound nearing the end of Phase II clinical development?
  • Are you planning for NDA or MAA submission?
  • Do you need to understand the human-specific metabolism of your compound?
  • Do you want to work with a partner that specialises in human ADME study delivery?

Quotient Clinical is the world’s leading provider of 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.

Our strengths

  • Human ADME tableIntegrated formulation development, real-time drug product manufacturing and clinical testing, significantly reducing the time and cost of bringing a drug to market
  • Expert medical and scientific interpretation and assessment of client requirements
  • Study design, delivery and reporting to the highest standards
  • Delivering comprehensive data to support global regulatory submission
  • Demonstrable track record of excellence in human ADME delivery

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

Download our Fact sheet, Case Studies and Scientific Publications

Advantages of an integrated Synthesis-to-Clinic® program

  • Single multidisciplinary service provider
  • Single project manager
  • Integrated quality process
  • Continuity of the science
  • Removal of overall management burden

Our capabilities in intravenous (IV) formulation development, real-time manufacturing and clinical testing allow us to generate IV pharmacokinetic and absolute bioavailability data – find out more

Download our Fact sheet, Case Studies and Scientific Publications

Human ADME for oncology drug development

If you want to perform a human ADME study for an oncology drug in cancer patients, we can supply 14C radiolabeled drug products to specialized clinics.

Our OncoADME™ service uses our real-time adaptive manufacturing approach to supply 14C radiolabeled drug products to specialist oncology clinics globally. Drug products are manufactured on a ‘per patient’ basis and supplied to the clinic for dosing within two weeks of patient enrolment. This streamlined approach tailors drug product manufacturing to patient recruitment, reducing overall project costs and enabling the management and control of any issues related to instability of the 14C radiolabel. 

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