Nonclinical toxicokinetic (TK) studies:

  • Support mammalian toxicology studies with TK data to correlate safety and drug blood levels in animal models.

Use latest industry standards with Covance:

  • WinNonLinTM and SASTM: comprehensive statistical data analysis for TK report integration into regulatory submissions

Pharmacokinetic (PK) screening:

  • Assess lead compound pharmacokinetics  
  • Predict metabolism/ PK in humans

Clinical PK/Bioavailability studies:

  • Clinical bioavailability studies for all major stages of drug development.
  • Measure rates of distribution and elimination, amount of drug at therapeutic site
  • Provide data to establish optimal dosage and dose frequency

Bioequivalency studies:

  • Compare pharmaceutical equivalents/alternatives to establish equivalent extents and rates of absorption.

Therapeutic drug monitoring studies with Covance Central Laboratory Services:

  • Integrated service with Covance Central Laboratories
  • Reduces errors, provides chain-of-custody sample tracking, coordinates sample shipments, integrated reports for regulatory submissions

Biomarker studies:

  • Support assay development, qualification and validation for preclinical and clinical studies

Drug-drug interaction studies:

  • Rapid method development for comparator studies
  • Publication of nonproprietary methods

Large Molecule Immunochemistry

Specialized capabilities:

  • Immunogenicity studies using four-tier approach
    • Screening
    • Confirmatory (immunodepletion)
    • Titer assessment (quantification)
    • Cell-based neutralizing antibody detection

Bioanalytical Methods List

Covance scientists routinely establish and validate proprietary and nonproprietary bioanalytical methods annually. Download our published, nonproprietary methods available as references in the public domain.

Service Profile

Download a service profile on Global Bioanalytical Capabilities and Instrumentation.