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:
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 studie
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
Rapid method development for comparator studies
Publication of nonproprietary methods
Immunogenicity studies using four-tier approach
Titer assessment (quantification)
Cell-based neutralizing antibody detection
Bioanalytical Methods List
Covance scientists routinely establish and validate proprietary and nonproprietary bioanalytical methods annually.
our published, nonproprietary methods available as references in the public domain.
a service profile on Global Bioanalytical Capabilities and Instrumentation.