PK/TK Analysis

Pharmacokinetic/Toxicokinetic Non-compartmental Analysis Services

Navigating pre-clinical regulatory safety assessments for drug candidate selection and characterizing pharmacokinetics (PK) within single studies to make dose escalation decisions are crucial steps in the drug discovery and development process. Non-compartmental analysis (NCA)—an approach often used to estimate PK and toxicokinetic (TK) parameters, such as clearance, elimination half-life, Tmax, Cmax, etc.—requires extensive expertise. Certara’s comprehensive PK/TK experts integrate proven and extensive pre-clinical and clinical expertise with advanced modeling and simulation approaches using Phoenix WinNonlin®, the industry standard for PK/PD modeling and simulation.

Leave the Navigation to Us

Certara PK/TK Services provides personalized, high quality GLP-approved reports to streamline clinical and pre-clinical studies so that you can achieve your development and regulatory goals faster and more efficiently. Certara also offers competitive pricing for high volume PK/TK reporting outsourced by CROs and pharma.

Our PK/TK range of services for discovery phase lead candidate selection encompass all major routes of administration and a wide range of matrices.

Small and large molecules
Serum, plasma, urine, tissue, CSF
PK/PD for biomarker evaluation
Anti-drug Antibody (ADA) Effect
Modeling and dose-response prediction
CDISC SDTM/SEND packages for PC and PP domains
GLP compliant/on-site QA auditing

Routes of Administration

Contact us to learn how our team of clinical and pre-clinical experts can help improve your R&D productivity and streamline compliance requirements.