Knowledge - based drug development consultancy
Exploratory clinical development specialists

HELPING TO ACCELERATE DRUG DEVELOPMENT

Garner Consulting based in York, UK, provides preclinical and clinical consultancy advice in pharmacology and toxicology.

Mass Spectrometer

In Vitro Metabolism

Headed by Professor Colin Garner, DSc FRCPath, Garner Consulting adds value to academia, pharmaceutical and biotechnology companies in their early-stage drug development programmes. Focussing on the critical steps required to ensure ‘druggability’, our consultancy advice addresses the key questions to enable go / no go decisions to be made on taking a drug forward.

The advice provided is on a need to know rather than a nice to know basis. As the best model for humans are humans, Garner Consulting is always seeking ways, together with the Client, to enable drugs to enter into humans in as cost-effective, safe and timely manner as possible. Garner Consulting uses Professor Garner’s expertise in xenobiotic metabolism gained over a lifetime’s career in academia mainly at the University of York and as a serial entrepreneur having founded three University of York spin-out companies (Microtest Research Ltd, Biocode Ltd and Xceleron Ltd). Solutions are provided to problems that can arise in the early stages of drug development or as a result of regulatory concerns during submission for drug registration.

Services provided include (click here for further details)

  • Genetic toxicology advice and interpretation
  • Advice on applications of Accelerator Mass Spectrometry (AMS)
  • Review, interpretation and advice on human ADME / PK studies

 

Tablets

  • Project management of exploratory clinical studies including;
    • Phase 0 microdosing studies providing early human pharmacokinetic (PK) / pharmacodynamic (PD) information
    • Mass balance and metabolite profiling to comply with US FDA and EMA regulatory requirements
    • Intravenous PK studies to provide Absolute Bioavailability parameters
    • Microdose studies for determining paediatric PK especially in the preterm – 2 year old age group