ADME / DDI / PK 

& Analytical Services

Remember: “One size fits nothing in ADMET/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 FDA guidances
  • 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

Analytical Services

CapEval Pharma can also provide analytical strategies in accordance with ICH standards and develop approaches for pre-clincial and clinical product development. 

We can help in the following areas:

  • Method development for API, impurities, genotoxic impurities
  • Development of validation protocols according to clinical phase or to ICH standards
  • Development of stability indicating methods
  • Impurities analysis -related substances, degradants and qualification
  • Reference standard qualification
  • Stability testing and data interpretation
  • Analytical method transfer and validation
  • Quality control
  • Setting specifications
  • Rapid bioanalysis – solid method development/sample analysis for complex approaches (e.g. cassette PK, tissue analysis)
  • GLP bioanalysis – method development/sample analysis under compliance with focus on ruggedness
  • Metabolite identification and bio-synthesis approaches


Specialities and Expertise:

  • Chromatographic separation (GC, HPLC, IC) and derivatization methods
  • ICP
  • Identification tests (NMR, IR, MS)
  • GC/MS and LC/MS technologies (triple quad, ion trap, TOF)
  • Genotoxic impurities
  • Polymorphic studies
  • Lipid analysis (total and free cholesterol, bile acids)
  • Isolation/characterization of metabolites using radiolabels
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