Drug Metabolism and Pharmacokinetics

We characterize how your compound is absorbed, distributed, metabolized, and excreted through a combination of in vitro assays, high-resolution metabolite identification, and pharmacokinetic analysis. Our DMPK services provide insights into metabolic stability, clearance pathways, and systemic exposure—supporting early decision-making, dose selection, and risk reduction ahead of clinical development.

Metabolite Identification & Profiling

Accelerate development with high-throughput metabolite identification using high-resolution mass spectrometry (HRMS). Our workflows enable rapid detection and structural characterization of metabolites to support lead optimization, safety assessment, and regulatory submissions.

Includes:

  • High-throughput metabolite ID using LC-HRMS

  • Structural elucidation of phase I and II metabolites

  • Metabolic pathway mapping in plasma, liver, bile, and urine

  • Support for metabolite profiling in safety and tox studies

Pharmacokinetic Sample Analysis

We generate high-quality PK data from preclinical studies using sensitive high-resolution LC-MS/MS methods and microvolume sampling techniques. Our workflows support a range of biological matrices and enable accurate characterization of systemic exposure and drug distribution.

Includes:

  • LC-MS/MS (HRMS) quantitation in plasma, serum, and tissue

  • Microvolume sampling (≥5 µL) for serial PK

  • Noncompartmental analysis (NCA): AUC, Cmax, t½, clearance, Vd

  • Plasma protein binding (fraction unbound)

  • Support for multiple species and dosing routes (IV, PO, SC, etc.)

Enzyme Kinetics & Drug-Drug Interaction Studies

Understanding your compound’s interaction with key metabolic enzymes and transporters is critical for assessing DDI risk and clinical safety. Our in vitro assays evaluate both reversible and time-dependent effects on major CYP450 isoforms.

Includes:

  • Enzyme kinetic analysis (Km, Vmax) to characterize metabolic pathways

  • CYP450 inhibition and induction assays (e.g., CYP3A4, 2D6, 2C9, 1A2, 2C19)

  • Time-dependent inhibition (TDI) to assess irreversible enzyme binding

PK Modeling & Simulation

We offer practical, data-driven pharmacokinetic modeling to help interpret preclinical results and guide early development decisions. By combining in vitro and in vivo data, we help estimate exposure, guide FIH dose planning, and contextualize preclinical PK results.

Includes:

  • Compartmental and noncompartmental PK modeling (NCA and parameter estimation)

  • First-in-human (FIH) dose approximation using allometric scaling

  • Simulation of dose-exposure relationships to support study design

  • Integration of LC-MS/MS and in vitro ADME data for model inputs