GLP Toxicokinetics
Build confidence in safety assessments with GLP-compliant toxicokinetics that connect exposure data to meaningful development decisions.
What is Toxicokinetics?
Toxicokinetics (TK) evaluates the relationship between drug exposure and observed toxic effects, helping to establish the No Observed Adverse Effect Level (NOAEL)—a critical benchmark for selecting safe and effective clinical doses. While pharmacokinetics (PK) typically focuses on therapeutic exposures, TK extends those principles to higher, potentially toxic concentrations to understand accumulation, changes in clearance and exposure, and dose-limiting exposure thresholds.
GLP-compliant TK studies provide the regulatory data required to support IND, NDA, and BLA submissions, while non-GLP exploratory dose range finding studies are appropriate earlier in development to save time and cost. In both cases, TK provides the foundation for linking preclinical safety based on exposure to first-in-human trial design and critical exposure stopping criteria.
Xyzagen’s GLP Toxicokinetics Capabilities
At Xyzagen, we design and execute TK studies across multiple species, integrating toxicology, bioanalysis, clinical, and regulatory expertise to ensure your data is both compliant and actionable.
Unlike large CROs, where TK groups are engaged after bioanalytical data is ready, we apply decades of hands-on experience to study design from the start—covering bioanalytical method validation, dose solution confirmation, and optimal time-point selection. Our approach maximizes the insights you gain from each study, just as we do in our First-in-Rat® and First-in-Mouse® programs. This philosophy ensures your TK studies inform safer and more efficient first-in-human trials.
TK Study Design & Execution
Single-dose and repeat-dose exposure assessments tailored to your compound and development stage.
Systemic Exposure & Dose-Proportionality
Evaluate drug accumulation, clearance, and dose-proportionality to support safety and dosing decisions.
Species Comparison & Translation to FIH Dosing
Bridge preclinical results to clinical expectations with translational PK analysis.
GLP & Non-GLP
High-quality data generation using LC-MS/MS, ligand-binding assays, and other validated approaches.
Regulatory-Compliant TK Reports
Robust reporting that meets FDA, EMA, and ICH requirements, ready to support IND, NDA, and BLA submissions.
Why Choose Xyzagen for GLP Toxicokinetics?
Many CROs focus only on generating TK data. Xyzagen goes further by integrating study design, bioanalysis, and regulatory expertise to ensure your results are not just compliant—but also meaningful for development strategy. Our senior scientists provide direct interpretation that links exposure data with safety findings, helping you build a stronger bridge to first-in-human studies and beyond.
Partner with Xyzagen
Need GLP Toxicokinetics support? Contact us today to discuss your program and learn how Xyzagen can deliver the insights you need for confident decision-making.
