DMPK Services

DMPK

Drug Metabolism and Pharmacokinetics (DMPK) data are critical for selecting the right candidates, de‑risking development, and meeting regulatory expectations. Our DMPK services help you understand how your molecules are absorbed, distributed, metabolized, and excreted, so you can move forward with confidence.

What We Offer

From early discovery through IND-enabling packages, the team supports both standalone studies and fully integrated programs.

• In vitro ADME: Solubility, permeability (Caco‑2, PAMPA), plasma protein binding, metabolic stability, CYP inhibition/induction, transporter assays.
• In vivo pharmacokinetics: Single- and multiple-dose PK, IV/PO studies, bioavailability, tissue distribution, PK/PD support in relevant preclinical species.
• Metabolite identification: Structure elucidation and profiling using LC‑MS/MS and high‑resolution MS to support safety and DDI assessment.
• Modeling and simulation: Data integration and PBPK/popPK modeling to support first‑in‑human dose projections and regimen optimization.
• Bioanalytical services: Method development, qualification/validation, and sample analysis using sensitive LC‑MS/MS platforms under appropriate quality frameworks.

Core in vitro DMPK assays

These studies are typically expected before or around first‑in‑human dosing.

• Physicochemical properties: Aqueous solubility, stability, and sometimes lipophilicity to support formulation and exposure predictions.
• Permeability: Caco‑2 or other permeability models to estimate oral absorption potential.
• Plasma protein binding and blood distribution: Binding in preclinical species and human to interpret exposure, free drug, and safety margins.
• Metabolic stability and pathways: Microsomal/hepatocyte stability and metabolite profiling in animal species and human; often used to guide choice of tox species.
• Enzyme phenotyping and DDI risk: CYP (and sometimes UGT/transporters) inhibition and induction screens to support early drug–drug interaction assessment for the IND narrative.

High-level summary table

In Vivo Pharmacokinetics (PK)

Our state-of-the-art vivarium and analytical suites provide high-resolution data on how your molecule moves through a living system.

• Multi-Species Profiling: Comprehensive PK studies (IV, PO, SC, IP) in rodent and non-rodent models.
• Bioavailability (F\%) & Clearance: Detailed analysis of absorption rates, half-life (T_{1/2}), and volume of distribution (V_{ss}).
• Tissue Distribution: Specialized studies for CNS penetration (Brain-to-Plasma ratios) and tumor-specific accumulation.
• Excretion & Mass Balance: Biliary and urinary excretion profiling using radiolabeled or cold compounds.

Core in vivo PK / ADME studies

These studies connect exposure, toxicity, and dose selection for clinical trials.

• Single‑dose PK in tox species: At or near doses used in repeat‑dose tox studies, typically in one rodent and one non‑rodent, to characterize systemic exposure and TK.
• Multiple‑dose PK/TK: When repeat‑dose tox is conducted, TK samples are collected to relate exposure to findings and to support safe starting dose and escalation scheme in humans.
• Bioavailability and basic disposition: Oral vs IV PK to estimate bioavailability; sometimes tissue distribution or limited QWBA/radiolabeled studies depending on risk and modality.
• Mass balance / excretion (as needed): Radiolabeled ADME/mass‑balance studies are often completed before or during early clinical phases to define routes of elimination and major metabolites.

In Vivo Pharmacology & Disease Models

We validate efficacy in translationally relevant models that mirror human disease pathology.

• Oncology: Syngeneic models, Cell-line Derived Xenografts (CDX), and Patient-Derived Xenografts (PDX).
• Inflammation & Immunology: Models for Arthritis (CIA/CAIA), IBD (DSS-induced Colitis), and Psoriasis.
• Metabolic Diseases: NASH, NAFLD, and glucose homeostasis models (GTT/ITT).
• Custom Model Development: Our PhD scientists can develop bespoke models tailored to your novel mechanism of action.

The Integrated PK/PD Advantage

We don't look at PK and Efficacy in isolation. We integrate them to define your molecule's Therapeutic Window.

• PK/PD Correlation: Simultaneous monitoring of drug concentration and biological effect (e.g., target occupancy or biomarker modulation).
• Dose-Response Optimization: Identifying the Minimum Effective Dose (MED) to guide Phase I clinical trial design.
• Human Dose Prediction: Utilizing allometric scaling and PBPK modeling to project safe and effective starting doses for humans.

Analytical Excellence (Bioanalysis)

Our bioanalytical lab utilizes high-sensitivity LC-MS/MS to ensure every data point is precise and reproducible.

• Rapid Discovery Phase Bioanalysis: 48-hour turnaround for early PK screening.
• Method Development & Validation: Non-GLP and GLP-compliant methods for complex matrices (tissue, bile, CSF).
• Small & Large Molecule Support: Expertise in both traditional small molecules and new modalities like PROTACs or peptides.