Preclinical Development

DMPK

Providing Scientific input to influence selection of lead drug candidates.

Proven Techniques and Best-in-class Approaches

Our scientific staff applies proven techniques and best-in-class approaches to generate data for critical milestones and decision making during drug discovery and development.

The highly trained and experienced scientific team provides broad and in-depth expertise/advice to clients on appropriate study designs, execution of studies, and interpretation of the data. We offer extensive drug metabolism and pharmacokinetic capabilities for new chemical entities and compounds in development.

Our DMPK Services

Target to Hits

Target and ADME screening

  • Chemical stability
  • Soft spot ID
  • Microsomal stability
  • Oncology xenograft model
  • Microbiome metabolism

Hits to Leads

Optimization of Druggable Properties

  • Metabolic stability
  • Cross species metabolite profiling
  • CYP/UGT phenotyping, inhibition, and induction
  • Reactive metabolites
  • Membrane permeability
  • Protein binding
  • Reactive metabolites
  • Animal PK (rodent)

Candidate
Identification

Optimization of Lead, IVIVE & PK/PD

  • Target tissue exposure
  • Blood/plasma ratio
  • IVIVE renal and biliary clearance
  • Mass balance
  • Metabolite ID
  • Transporter phenotyping and inhibition
  • Metabolite synthesis
  • Stable isotope labeling
  • Radiolabeling

Toxicological and safety evaluation

Assessment of Dose Range & Safety/Tox

  • Animal PK (non-rodent)
  • Interspecies scaling
  • Dose range finding
  • Tissue distribution
  • Bile duct cannulation
  • Food effect
  • Metabolite profiling
  • Toxicokinetic
  • CYP induction
  • QWBA

Clinical I, II, III, research

Characterization of Safety/Tox

  • Circulating metabolites (MIST)
  • Definitive human metabolite profiling
  • Human ADME (4Q2020)

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