Absorption, Distribution, Metabolism and Excretion (ADME)
Collaborative characterisation for informed development
There’s nothing worse than the unexpected when it comes to Drug Development and we are committed to providing our clients with tailored investigations from Late Lead Optimisation through to launch, navigating and anticipating the regulatory requirements for each specific project.
The key to your success is addressing the most relevant questions at the most appropriate stage; abandoning a ‘box-ticking’ approach in favour of contextualised data-lead-development means that we work to characterise the Absorption, Distribution, Metabolism and Excretion of assets without ever losing sight of your end goal and the patients who are waiting for your medicines.
Customized to assess formulation alternatives including bioenhanced options and relative bioavailability comparisons as well as bridging studies, toxicokinetic profiling and investigative pharmacokinetic studies.
Mass balance, QWBA and tissue distribution, plasma protein binding and blood cell binding studies as well as mechanistic enzymatic investigations are all run from our dedicated on-site radioactivity suites with efficiency gains available to clients wishing to transfer samples, for example, from an excretion balance study into an ex vivo metabolite profiling study.
Metabolite Profiling and Identification
Cross species metabolite profiling and structural elucidation in samples from mass balance and PK studies as well as available toxicokinetic and clinical samples are studied under a range of available protocols including the invaluable Metabolites In Safety Testing (MIST) approach.
In vitro Studies
Metabolic stability, tissue binding and distribution, inhibition, induction, and phenotyping for a range of enzyme families as well as transporters are all performed according to protocols designed around your needs and phase of development and can feed into a customized evaluation of your drug-drug interaction potential with due consideration to a host of other data.