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ADME/DDI/PK

Remember: “One size fits nothing in ADMET/PK”

  • when to use recombinant versus microsomal CYP inhibition?
  • when should you use a cassette versus discrete PK approach?
  • what exactly is PK/PD in your project?
  • can you use the rat alone to predict human PK?

No matter if your project is in early drug discovery, lead optimization or already in candidate profiling during pre-clinical development, CapEval Pharma can help to find the right assay conditions to improve, fine-tune and/or fully characterize drug-likeness, ADME, DDI potential and cross-species PK including human PK and dose prediction. 

 

We can help you with:

  • Evaluation of in silico data and physicochemical properties
  • Proposal for early high throughput ADME assays
  • Detailed SOPs and technical help for all advanced ADME assays
  • Metabolite identification incl. CYP or other enzyme mapping
  • Transporter evaluation (substrate and inhibition format)
  • Advice how to approach new 2012 FDA guidance for DDI
  • Metabolites in safety testing (MIST FDA Guidance)
  • Toxicophores and reactive intermediate assays
  • New early safety assays (e.g. HCS screening, Greenscreen)
  • CYP induction studies
  • Design and conduct of PK experiments (in house or CRO) for rodents, rabbit, dog, minipig, NHP
  • Target-specific PK/PD approaches
  • Allometry, human PK and dose prediction
  • Radiolabeled in vitro met ID in combination with rodent/non-rodent mass balance/metabolite profiling, QWBA
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