Which PK Assay, Pharmacokinetics Study, And Pharmacokinetics CRO Services Do We Offer?
Comprehensive Suite Of PK CRO And PK Sample Analysis Services To Assess your Drug Exposure and Therapeutic Potential From Early Development To PK Clinical Trials And Beyond!
PK Assay Development, Optimization, or Method Transfer
- Design and optimize PK Assay using Column Chromatography (LC-MS/MS or HPLC-UV/DAD) Method Development
- Ligand-binding (Direct, Indirect, Sandwich, Competitive) PK ELISA Assay, Mesoscale Discovery, Or Hybrid Assay for Biologics, Proteins, Oligonucleotides, etc
Pharmacokinetics Assay Validation Services
- Fit-for-purpose (FFP) as per FDA Bioanalytical Method Validation Guidance (GLP, GCLP) in the Context-of-Use (COU)
- Suitable calibration range for any given PK blood sample collection, preparation, and storage limitations
Pharmacokinetic (PK) Assessment For Safety and Efficacy
- GLP Pharmacokinetic studies in rodents and large animals as well as analysis of PK blood samples in clinical trials
- ADME, biodistribution, and bioavailability evaluation in multiple matrices including plasma/serum, urine, CSF, stool, cell lysates, and tissue homogenates
PK Parameter Analysis using Certara's WinNonlin™
- PK CRO services to determine clearance (Cl/F), the volume of distribution (Vz/F), maximum concentration (Cmax), time of maximum concentration (Tmax), elimination half-life (t1/2), the area under the curve (AUC), Lambda Z, and other relevant PK parameters
- PK and PD analysis for further development and validation of Pharmacodynamic activity, immunogenicity (ADA), and neutralizing antibody (nAb) Assays
Preclinical and Clinical PK Lab Support Services
- Preclinical pharmacology, enzyme induction/inhibition, metabolic stability, protein binding, DMPK, Or ADME Lab and research services
- Exposure, half-life, clearance, and drug tolerance input for Pharmacodynamic Or
immunogenicity (ADA)
Stability Testing Pharmacokinetics Lab Services
- Qualify PK Sample analysis following long-term storage
- PK Assay set-up and test run(s) for stock solutions, calibration curve, and quality controls