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Toxicokinetics

Toxicokinetics (TK) is the analysis of analyte concentration data collected during nonclinical safety / toxicology studies conducted in animals.  The goal of TK is to correlate findings of toxicity with a corresponding level of drug exposure.

Including toxicokinetics in a toxicology study is important to confirm systemic exposure to the test material and establish exposure parameters of the NOAEL (No Observed Adverse Effect Level).  The NOAEL is the highest dose and associated exposure level where no toxicity to the test material is observed.  Knowledge of the NOAEL is a critical piece of data necessary for conducting early clinical trials in humans.

Besides confirming exposure and establishing exposure parameters associated with the NOAEL, TK is necessary to identify potential gender differences, dose-limiting absorption and/or metabolism.  This information may confirm suitability of the animal species used in the toxicity evaluations (relevance to humans), potential gender differences in humans, dose selection (maximum feasible dose), accumulation, and/or induction/inhibition of metabolism.

Our TK experience covers every route of administration, type of toxicity study, and expertise in complex nonclinical study designs.  In addition, our clients have direct access to some of the most experienced TK scientists in the industry.

Nuventra’s team of consultants and staff fully versed in these investigations has the capabilities to conduct both Good Laboratory Practices (GLP) and non-GLP TK analyses.

Our Toxicokinetics (TK) Services:

  • GLP and non-GLP TK analyses
  • Study design including dose selection, frequency and sample collections
  • Nonclinical protocol development
  • GLP-compliant validated computing environment for conducting TK analyses
  • Rapid and thorough Quality Assurance Unit (QAU)
  • Onsite archiving of GLP study materials
  • Robust report templates

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