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:

• WinNonLin^TM and SAS^TM: 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