Pharmacokinetics (PK)
High-Quality PK Reporting and Regulatory Documentation ensuring Compliance
Pharmacokinetics (PK)
Pharmacokinetics studies investigate the absorption, distribution, metabolism, and excretion of new chemical entities.
Following completion of bioanalytical quantification, we perform pharmacokinetic data analysis using validated platforms such as Phoenix WinNonlin to ensure robust, precise, and regulation‑compliant results.
PK parameters—including Cmax, Tmax, AUC, t½, CL/F, Vz/F and others—are calculated according to established guidelines to guarantee reproducibility and reliability.
Our scientific expertise allows us to interpret these data effectively and translate them into clear, well‑structured regulatory documentation, including IND‑supporting sections and Investigator’s Brochures.
Finally, pharmacokinetic outcomes are integrated with pharmacodynamic and toxicology insights to justify dosing decisions and support the overall drug‑development strategy.