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
- Compare pharmaceutical equivalents/alternatives to establish equivalent extents and rates of absorption.
- Integrated service with Covance Central Laboratories
- Reduces errors, provides chain-of-custody sample tracking, coordinates sample shipments, integrated reports for regulatory submissions
- 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
- Immunogenicity studies using four-tier approach
- 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.
Download a service profile on Global Bioanalytical Capabilities and Instrumentation. |