We provide extensive pharmacokinetic (PK) and pharmacodynamic (PD) support - as part of our Biostatistics services - in Phase 1-3 clinical studies in accordance with international regulatory standards (FDA, EMEA, and ICH).
We offer human pharmacology services that include, but are not limited to, single- and multiple-dose PK studies, bioavailability studies, bioequivalence studies, drug-drug interaction studies (DDI), population PK, and PK/PD or dose-response studies.
Additionally, we provide the following related services to our biopharmaceutical clients:
- Pharmacokinetic study design
- Consulting and liaison with regulatory agency officials
- Pharmacokinetic protocol authorship
- Pharmacokinetic data analysis and modeling
- Pharmacokinetic clinical study report writing