DMPK

Our Drug Metabolism and Phamacokinetics Team provides expertise in DMPK studies at all stages of R&D—from lead optimization through NDA.

We can assign a pharmacokineticist to provide expert evaluation of your drug candidate whether your study is performed at Seventh Wave or at another laboratory. The same pharmacokineticist can stay with your candidate, providing scientific continuity and consistency of evaluations throughout the life cycle of your compound.

Services include:

  • PK studies
  • A wide variety of protocols for all parameters, including:
    • Total and renal clearance
    • Volume of distribution
    • Terminal half-life
    • Bioavailability
    • PH Telemetry System Remote Measurement of Gastrointestinal pH in dogs
    • Bile duct cannulated models

PK/TK Analysis of data from client companies

  • GLP Compliant
  • Validated software, data handling SOPs, internal and external audit capabilities
  • Phoenix® WinNonlin® software; Validated, part 11 compliant
  • Non-compartmental and compartmental analyses
  • Bioequivalence/bioavailability assessments
  • Evaluation of dose, drug interactions, and more
  • Leverage preclinical data for clinical PK projections

Document Generation and Quality Systems

  • Provide or assist with protocol writing
  • Flexible report formats
  • Write or support technical and regulatory reports
  • Assist with publications, abstracts, and posters
  • Document Specialists and Quality Assurance Unit support

 

Click here to download more information about these services.