Drug Metabolism and Pharmacokinetics (DMPK) is the broader scientific discipline focused on understanding how a drug behaves in the body and how exposure relates to efficacy and safety. ADME—Absorption, Distribution, Metabolism, and Excretion—represents the core studies and processes that generate the data used in DMPK decision-making. ADME studies are also the traditional sections of module 2.6.4 for the nonclinical PK section of the IND.
LAB SERVICES
DMPK & ADME Studies
Comprehensive in vitro and in vivo DMPK and ADME studies to support pharmacokinetics, safety, and formulation strategies.
What is DMPK?
DMPK is short for Drug Metabolism and Pharmacokinetics and evaluates how a compound behaves in the body and how those properties influence its safety and efficacy. DMPK integrates in vitro assays, in vivo studies, bioanalysis, and modeling approaches to support candidate selection, lead optimization, and translational drug development.
DMPK plays a critical role in translating promising compounds into viable drug candidates by assessing their ADME and pharmacokinetic (PK) properties and identifying factors that may impact exposure, efficacy, and safety. ADME data form the foundation of DMPK research and are essential for understanding a compound’s pharmacokinetic profile.
What is ADME?
ADME is short for Absorption, Distribution, Metabolism, and Excretion and describes the biological processes that determine the fate of a drug within the body. Understanding these properties is essential to evaluating how a compound is absorbed into circulation, where it travels, how it is metabolized, and how it is ultimately eliminated.
ADME studies help predict a drug’s pharmacokinetic (PK) profile, optimize dosing strategies, and identify potential safety concerns early in development. These data also support regulatory submissions and guide decisions in lead optimization, formulation, and toxicology studies.
Core ADME Capabilities
From early discovery and lead optimization to IND-enabling studies, we provide expert support across all aspects of ADME (absorption, distribution, metabolism, and excretion) to inform PK profiling, compound screening, formulation and dose selection, biomarker strategies, safety assessments, and regulatory decision-making.
In Vitro ADME Assays
Our in vitro assays help predict how a drug candidate will behave in vivo—reducing reliance on animal studies and enabling early optimization of compound properties. Xyzagen offers a wide range of industry-standard assays, including:
- Metabolic stability using hepatocytes, microsomes, and S9 fractions
- CYP450 inhibition and induction to assess DDI potential
- Plasma protein binding for distribution prediction
- Permeability assays (e.g., Caco-2) for intestinal absorption potential
- pH stability and solubility profiling
In Vivo ADME Studies
Our in vivo ADME studies evaluate the full pharmacokinetic (PK) profile of your compound in relevant animal models—providing critical data on systemic exposure, tissue distribution, and clearance pathways through:
- Absorption and oral bioavailability assessments
- Tissue distribution studies via whole-body sampling
- Excretion profiling through urine, feces, and bile collection
- Mass balance and metabolite recovery studies
Bioanalytical Support for ADME Studies
Quantitative bioanalysis is a critical pillar of ADME research. Xyzagen supports your studies with high-sensitivity LC-MS/MS and ligand-binding assays for accurate drug quantification, including:
- Plasma, tissue, urine, and feces analysis
- Support for pharmacokinetic, toxicokinetic, and DMPK studies
- Method development and assay transfer for GLP validation
- High-throughput workflows with rapid turnaround to support discovery-stage decisions
DMPK & ADME Studies at Xyzagen
At Xyzagen, we offer comprehensive DMPK and ADME studies through our in-house wet lab, integrated preclinical platform, and First-in-Rat® and First-in-Mouse® discovery programs designed to accelerate candidate selection and development decisions. Our in vitro and in vivo capabilities are designed to generate high-quality, decision-enabling data with rapid turnaround.
We also augment physiologically based pharmacokinetic (PBPK) modeling by generating critical in vitro data that may be missing from a client’s internal studies. These customized studies strengthen model predictions and inform better dosing and formulation strategies.
Why Choose Xyzagen for Your ADME Studies?
Xyzagen delivers more than data—we provide actionable insights. With a tightly integrated lab infrastructure, First-in-Rodent® platforms, and a team of seasoned pharmacokinetics experts, we offer:
Tailored ADME study designs aligned with your compound’s properties
End-to-end support from early screening through IND
Flexible, scalable workflows for fast-moving discovery programs
Clear interpretation of results to drive formulation, dosing, and safety decisions
Frequently Asked Questions
Why are DMPK and ADME studies important in drug development?
DMPK and ADME studies help identify potential development risks early by evaluating how a compound is absorbed, distributed, metabolized, and eliminated. These data support lead optimization, candidate selection, dose prediction, formulation strategies, and regulatory submissions. In the regulatory submissions, these sections are the basis of the IND and NDA or BLA submissions and help guide an understanding of what the body does to the drug.
When should ADME studies be conducted during drug development?
ADME studies typically begin during lead optimization and continue into candidate selection and throughout nonclinical development. Early ADME data help prioritize promising compounds, while later studies support IND-enabling programs, toxicology assessments, and clinical development planning.
What types of compounds can be evaluated in DMPK studies?
DMPK studies can support a wide range of therapeutic modalities, including small molecules, biologics, peptides, oligonucleotides, gene therapies, and other emerging drug platforms. Study designs are tailored to the unique characteristics of each compound. There are no regulatory guidelines on the design of DMPK studies other than ICH M12 for the specific in vitro and in vivo DDI (drug drug interaction) studies.
What are the most common in vitro ADME assays?
Common in vitro ADME assays include metabolic stability studies, CYP450 inhibition and induction assessments, plasma protein binding, permeability assays, solubility testing, and transporter interaction studies. These assays help predict in vivo pharmacokinetics and potential development risks. ICH M12 provides some guidance regarding the few important in vitro drug drug interaction studies that have been identified over the last few decades that inform most of our understanding bout potential clinically relevant drug-drug or drug-food interactions.
How do DMPK studies support PBPK modeling?
Physiologically based pharmacokinetic (PBPK) models rely on high-quality in vitro and in vivo DMPK data, as well as physiochemical property data, to predict drug exposure and potential drug-drug interactions (DDI) in humans. Studies such as metabolic stability, protein binding, permeability, and tissue distribution, and target engagement provide critical inputs that improve model accuracy and support dose selection.
How do I choose the right DMPK and ADME CRO for my biotech program?
An effective DMPK partner should provide integrated capabilities across bioanalysis, in vitro ADME, in vivo pharmacokinetics, and modeling. Access to experienced scientists who can interpret data and recommend next steps is often as important as the studies themselves.
Contact Us
Partner with Xyzagen to accelerate your path from lead optimization to clinical readiness. Contact us today to learn how our ADME studies can help you make informed development decisions with confidence and speed.
