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
- Translational research
- Authoring nonclinical sections of regulatory documents