Regulatory-Ready Bioanalysis for DMPK and Drug-Drug Interaction Studies
Emery Pharma provides DMPK and drug-drug interaction bioanalytical services for the quantification of drugs and metabolites in biological matrices to support ADME characterization, pharmacokinetic evaluation, and interaction assessment. These services help drug development teams generate the exposure and metabolism data needed to guide candidate selection, dose strategy, and preclinical to clinical decision-making. Using advanced mass spectrometry platforms and workflows aligned with ICH M10 and applicable FDA guidance, Emery Pharma supports pharmaceutical and biotechnology companies with precise, high-quality bioanalytical data for regulatory and development programs.
Service Areas Supporting Exposure, Safety, and Regulatory Evaluation
Our DMPK and DDI bioanalytical services help characterize drug exposure, metabolic pathways, and interaction risk across preclinical and clinical development. Together, these capabilities support informed decisions on candidate progression, dose strategy, and regulatory evaluation.
PK Bioanalysis for DMPK Studies
Description
This service provides design, analysis, and interpretation of preclinical DMPK studies to precisely quantify drug and metabolite concentrations in biological samples, enabling pharmacologists to make informed decisions on ADME profiles and drug development optimization.
Methodology
Emery Pharma utilizes high-resolution mass spectrometry (HRMS), LC-MS/MS, MSD, and ELISA techniques to perform sensitive and accurate quantification. Analytical methods are developed and validated following ICH M10 bioanalytical guidelines and FDA bioequivalence (BA/BE) and pharmacokinetics (PK) guidance, ensuring GLP-compliant data generation.
Deliverables
- Validated bioanalytical methods
- Quantitative concentration data for parent drugs and metabolites
- Comprehensive study reports supporting regulatory filings
- Data packages suitable for IND and NDA submissions
Immunogenicity & Anti-Drug Antibody (ADA) Testing Service
Description
Assessment of immune responses including detection of anti-drug antibodies in biologics development programs, critical for safety monitoring and regulatory compliance.
Methodology
Employing the Meso Scale Discovery (MSD) platform, Emery Pharma conducts immunogenicity assays in alignment with FDA/EMA immunogenicity guidance and ICH M10 when applicable. These assays evaluate ADA immunogenicity profiles in clinical and preclinical samples.
Deliverables
- Immunogenicity assay validation data
- Comprehensive immunogenicity assessment supporting regulatory submissions
Drug-Drug Interaction (DDI) Studies
Description
This service critically supports drug development and regulatory submissions. We utilize multiple sensitive techniques to quantitatively evaluate changes in the metabolism of a probe drug such as midazolam or rifampin to assess if co-administered compounds inhibit or induce the key metabolizing enzyme CYP3A4, crucial for DDI risk assessment.
Methodology
Using HRMS and LC-MS/MS, Emery Pharma measures probe drug and metabolite levels with high sensitivity. Methods comply with ICH M12 guidance, enabling reliable assessment of CYP3A4 enzyme activity modulation in preclinical and clinical samples.
Deliverables
- Quantitative data on probe substrate and metabolite concentrations
- DDI evaluation reports outlining inhibition or induction potential
- Method validation and assay performance documentation
Metabolite Analysis Service
Description
Comprehensive identification, structural characterization, and quantitative profiling of drug metabolites across in vitro and in vivo systems to inform metabolic pathways, exposure, bioactivation risks, and regulatory safety assessments.
Methodology
Utilizing HRMS, LC-MS/MS, and GC-MS, Emery Pharma conducts metabolite profiling adhering to FDA’s guidance on safety testing of drug metabolites. Advanced analytical techniques provide detailed metabolite structure elucidation and quantitative data.
Deliverables
- Metabolite identification and profiling reports
- Quantitative metabolite concentration data
- Regulatory-compliant metabolite safety assessment documentation
Discuss Your DMPK Study
Our Scientists
Stephanie Tan, Ph.D. brings extensive expertise in analytical and bioanalytical method development supporting pharmaceutical research and drug development. At Emery Pharma, she contributes to analytical and bioanalytical method development, with a strong foundation in method validation, chromatography, and mass spectrometry for qualitative and quantitative applications under R&D and GxP regulations. Her experience includes maintaining and optimizing analytical workflows that support rigorous drug development programs. Stephanie’s background makes her well aligned to support PDMPK and drug-drug interaction studies requiring robust quantitative bioanalysis.
projects delivered on time
average lead time for study initiation
response time to new requests
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Applicable Standards
ICH M10 (Bioanalytical), FDA BA/BE and PK guidance, ICH M12 (for DDI studies)
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Target Product / Molecule Type
Small Molecules, Biologics, Peptides
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Instrumentation & Analytical Platforms
High Resolution Mass Spectrometry (HRMS), Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), Meso Scale Discovery (MSD) electrochemiluminescence, and microplate spectrophotometer
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Sample Requirements
Biological matrices including plasma, serum, tissue; reference standards for analytes and metabolites
Why Choose Emery Pharma for Quantitative Bioanalytical Services
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GLP/GMP Compliance
Emery Pharma operates under strict GLP and cGMP standards, ensuring all bioanalytical methods and data are generated in compliance with regulatory frameworks such as ICH M10 and FDA guidelines, providing clients with confidence in data integrity for submissions. -
Regulatory Expertise
Our team’s deep understanding of global regulatory bioanalytical requirements, including ICH M10 and M12 guidance for DMPK and DDI studies, helps clients avoid pitfalls and streamline approval processes.
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Breadth of Instrumentation and Methodologies
Emery Pharma leverages advanced HRMS, LC-MS/MS, and MSD platforms that enable sensitive and precise quantitation across diverse molecule types, from small molecules to biologics and peptides. This ensures versatile and reliable bioanalytical solutions. -
Rapid Turnaround Times
We balance scientific rigor with operational efficiency by delivering timely results tailored to your project timelines, without compromising data quality or regulatory compliance. -
Cross-Industry Experience
Serving pharmaceutical and biotechnology sectors alike, our experts bring nuanced insight into drug metabolism and pharmacokinetics challenges across therapeutic modalities, strengthening your drug development program.
State-of-the-art instruments used in quantitative bioanalysis. Top left: HR LC-MS, top right: MSD instrument, Bottom: LC-MS
Supporting In Vitro ADME and DMPK Assay Capabilities
In addition to quantitative bioanalytical support for pharmacokinetic, metabolite, and drug-drug interaction studies, Emery Pharma offers a broader set of in vitro ADME and DMPK assays to help characterize absorption, distribution, metabolism, transporter interactions, and related physicochemical properties. These capabilities can support candidate selection, mechanistic evaluation, and study planning across drug development programs. The tables below summarize selected assay areas and their role in evaluating compound behavior and interaction risk.
Permeability and Transporters
| Assay | Why is it important? | How do we do it? |
|---|---|---|
| Caco-2 | Drug absorption is determined by polarized epithelial cells along the intestinal wall. Factors such as intestinal absorption, solubility, permeability, and dissolution rate play critical roles. Differentiated Caco-2 cells is the gold standard for evaluating passive and active transport of orally administered drugs. | Using transwell inserts, Caco-2 cells are cultured till confluence and tested for membrane integrity. Once achieved, test articles are applied to the apical or basolateral side to determine the permeability and efflux ratio. |
| Parallel Artificial Membrane Permeability Assay (PAMPA) | Nearly 80-95% of available xenobiotics are absorbed through passive diffusion. | Using a lipid-oil-lipid artificial membrane, test articles are added to the donor compartment and passively diffused to the acceptor region. Compared with monolayer-type assays such as Caco-2, this is significantly faster and only determines passive diffusion as there is no metabolism or transporters. |
| MDR1-MDCK | P-glycoprotein (P-gp) is a well-recognized efflux transporter almost ubiquitously expressed in tissues and organs. MDR1-MDCK cell lines encode this protein making them valuable tools for understanding P-gp substrates or inhibitors. | Using transwell inserts, MDR-1MDCK cells are cultured till confluence and tested for membrane integrity. Once achieved, test articles are applied to the apical or basolateral side to determine the permeability and efflux ratio. |
Drug Distribution
| Assay | Why is it important? | How do we do it? |
|---|---|---|
| Plasma Protein Binding | Typical drug distribution involves the movement of drugs from one location to another via blood to tissues. This distribution is dependent upon many aspects, including binding to proteins within plasma. This binding may limit the amount of free drug to act on targets or lead to reduced drug clearance. | Using rapid equilibrium dialysis (RED), a semipermeable membrane separates a protein containing chamber from a non-protein containing chamber. Following equilibration, test articles are quantified in each chamber. |
| Blood Plasma Partitioning | Typical PK profiles determine drug concentrations in plasma, not whole blood. However, if significant amounts of drug are bound to blood, data may be misleading and have significant consequences on clinical outcomes and toxicity. | Test article is added to whole blood and allowed to incubate. Following centrifugation to separate plasma from whole blood, drug levels are determined in each matrix to understand blood plasma partitioning. |
| Microsomal Binding | Only unbound drugs can interact with drug-metabolizing enzymes in microsomes. Elucidating the relationship between microsomal binding allows more accurate correlations and data interpretation between in vitro metabolism data and in vivo PK data. | Using equilibrium dialysis, microsomes are added to one chamber prior to addition of drug/substrate. Following an incubation period, drug quantification is done on both chambers to determine microsomal binding. |
In Vitro Metabolism
| Assay | Why is it important? | How do we do it? |
|---|---|---|
| Hepatocyte Stability | Drug metabolism primarily occurs in the liver. Hepatocytes contain all Phase I and Phase II enzymes serving as the gold standard for these assays. | Test articles are incubated with hepatocytes and samples are withdrawn at different timepoints. Test articles are then quantified throughout the sampling periods to determine drug clearance and half-life. |
| S9 Stability | Drug metabolism primarily occurs in the liver. Similar to hepatocytes, 9000g supernatant (S9) contain most Phase I and Phase II enzymes. S9 fractions can provide a qualitative assessment of with metabolites can be formed by cytosolic enzymes. | Test articles are incubated with S9 fractions and associated co-factors and samples are withdrawn at different timepoints. Test articles are then quantified throughout the sampling periods to determine drug clearance and half-life. |
| Microsomal Stability | Drug metabolism primarily occurs in the liver. Microsomes from the liver contain Phase I enzymes, notably the cytochrome P450 enzymes. | Test articles are incubated with microsomes, and co-factor NADPH and samples are withdrawn at different timepoints. Test articles are then quantified and monitored over the study period (typically <1 hour). |
| Metabolite Identification (MetID) | Drug metabolism is the main clearance mechanism for most drug compounds. Knowing the structures of the metabolites formed is extremely valuable for efficacy and safety profiles of candidate compounds. | Using our in vitro stability assays, Emery Pharma is well equipped to determine in vitro metabolites using HPLC-MS/MS, HR-MS, and NMR spectroscopy. Additionally, assays may include radio labeled detection using 3H or 14C. |
Drug-Drug Interactions (DDI)
| Assay | Why is it important? | How do we do it? |
|---|---|---|
| Cytochrome P450 (CYP450) Induction | CYP enzymes play a significant role in drug metabolism and are associated with DDI. If CYP450 enzymes are induced, drug metabolism may increase leading to lower-than-expected plasma levels and potential decreases in efficacy. | Using an induction kit, key CYP450 isoforms can be measured at the protein level following incubation with test articles and appropriate inducting compounds. |
| Cytochrome P450 Inhibition | CYP450 enzymes play a significant role in drug metabolism and are associated with DDI. If CYP450 enzymes are inhibited, drug metabolism may decrease leading to higher-than-expected plasma levels and potential toxicity. | Using an inhibition kit, key CYP450 isoforms can be measured at the protein level following incubation with test articles and appropriate inhibiting (isoform specific substrate) compounds. |
| UGT Induction | Uridine 5'-diphospho-glucuronosyltransferase (UGT) is the primary enzymes involved with glucuronidation, a Phase II metabolic process. Similar to CYP450 enzymes, understanding candidate compounds interplay with UGTs can be valuable for identifying DDIs. | Using an induction kit, key UGT isoforms can be measured at the protein level following incubation with test articles and appropriate inducting compounds. |
| UGT Inhibition | Uridine 5'-diphospho-glucuronosyltransferase (UGT) is the primary enzymes involved with glucuronidation, a Phase II metabolic process. Similar to CYP450 enzymes, understanding candidate compounds interplay with UGTs can be valuable for identifying DDIs. | Using an inhibition kit, key UGT isoforms can be measured at the protein level following incubation with test articles and appropriate inhibiting (isoform specific substrate) compounds. |
| Reaction Phenotyping | CYP enzymes play a significant role in drug metabolism and are associated with DDI. Knowing the specific enzyme responsible will help identify potential DDIs. | Test article is incubated with single CYP isoform. Test article concentration is then monitored throughout sampling periods. |
Physicochemical Characterization
| Assay | Why is it important? | How do we do it? |
|---|---|---|
| Lipophilicity | Key physiochemical parameter in drug discovery process, which indicates drug absorption and distribution to predict biological, pharmacokinetics, and metabolic properties of drug candidate. | Lipophilicity can be measured by the distribution of a drug between the organic phase, which is generally n-octanol pre-saturated with water, and the aqueous phase, which is generally water pre-saturated with n-octanol. |
| Chemical Stability | With orally administered drugs, candidate compounds must remain stable in the low pH stomach environment. Knowing compound stability is essential for predicting oral administration suitability. | Compound stability in different pH buffers and simulated gastric fluid (SGF) |
| Microsomal Binding | Only unbound drugs can interact with drug-metabolizing enzymes in microsomes. Elucidating the relationship between microsomal binding allows more accurate correlations and data interpretation between in vitro metabolism data and in vivo PK data. | Using equilibrium dialysis, microsomes are added to one chamber prior to addition of drug/substrate. Following an incubation period, drug quantification is done on both chambers to determine microsomal binding. |
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DMPK and DDI Bioanalysis FAQs
What DMPK bioanalytical services do you provide?
We provide end-to-end bioanalytical support for pharmacokinetic (PK) studies, drug–drug interaction (DDI) assessments, metabolite identification and quantification, Immunogenicity and ADA testing, pharmacodynamics (PD) biomarker and cytokine analysis. Our workflows integrate LC-MS/MS quantitation and MSD based analysis for concentration and immunoassays to support preclinical through clinical programs.