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 undertake any or all of these components on your behalf.
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
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.