Comprehensive PK/PD Services
From bioanalysis to modeling, we do it all.
Core capabilities
Bioanalytical Method Development & Validation
LC-MS/MS & immunoassay method design, optimisation, and validation to FDA, EMA & ICH standards.
Clinical Sample Analysis
GLP-compliant analysis of plasma, serum, urine, and other biological samples.
Pharmacokinetic (PK) Analysis
Full PK parameter calculation: Cmax, Tmax, AUC, t½, CL, Vd, with noncompartmental and compartmental analysis.
Our competencies
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Pharmacodynamic (PD) Biomarker Assessment
Enzyme inhibition, receptor binding, cytokine levels, and viral load reduction.
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PK/PD Modeling & Simulation
Integrate data using NONMEM, Phoenix WinNonlin, and Monolix to predict optimal dosing regimens.
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Bioavailability & Bioequivalence Studies
Analytical and statistical support ensuring test/reference formulation equivalence.
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Metabolite Profiling & Identification
High-resolution LC-MS/MS to identify metabolites and potential interaction risks.
Operational excellence
Sample Management & Logistics
Kit prep, labeling, cold-chain logistics, secure storage & chain-of-custody.
Quality Assurance & Regulatory Reporting
GLP compliance, QA audits, and regulatory-ready reports in CDISC/SDTM format.
Exploratory & Translational Biomarker Research
Fit-for-purpose assays to support early-phase and precision-medicine studies.
Stability & Matrix Effect Testing
Verification of analyte reliability under real-world sample handling.
Data Integration & Reporting
Seamless EDC/CDMS compatibility for end-to-end data traceability.