Toxicokinetics (TK)

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

GLP TK Analyses:

  • Fully GLP compliant facility for conducting TK analyses.
  • GLP-compliant validated computing environment for conducting TK analyses
  • Full complement of Standard Operating Procedures (SOPs) and Working Practices (WPs) to enable GLP-TK analyses.
  • Rapid and thorough Quality Assurance Unit (QAU).
  • Onsite archiving of GLP study materials.ew
  • Robust report templates that allow for thorough presentation and interpretation of TK data.

 

In addition to GLP and non-GLP TK analyses, Nuventra can provide overall nonclinical strategy to support clinical pharmacology investigations and overall drug development programs, including:

  • Incorporation of preclinical results within model-based drug development
  • Nonclinical vendor identification & management
  • Nonclinical pharmacology
  • In vitro investigations
  • Protein binding
  • CYP & Transporter drug-drug interactions
  • Bioanalytical
  • Toxicology
  • Translational research
  • Authoring nonclinical sections of regulatory documents