Pharmacokinetic and Mass Spectrometry (PK) Core Services
Drug Discovery, Development and Clinical Translation of Novel Therapeutics
8,500
Compounds
Supported
$260M
Supporting Grant Funding
to U-M
90+
Labs
Serviced
7
Patents
Issued
218
Publications
A Track Record of Supporting:
quantitative LC-MS analysis of molecules and mass spectrometry imaging of spatial localization biomarkers in tissue section.
preclinical ADME and pharmacokinetics for lead compound optimization in drug discovery and development.
clinical pharmacokinetics and dosage regimen design for clinical trials.
PKMS Services
We offer a variety of partnership options, including collaboration, fee-for-service and self-service. The PKMS core facilitates researcher efforts to discover new medicines, obtain research funding, file patent applications and publish academic research findings.
Explore all the ways we can work together.
Bioanalysis and LC-MS
In partnership with Michigan Drug Discovery, we analyze drug/compound concentration in biological specimens and develop assays, having measured more than 2,300 compounds including commercially available drugs.
Small Molecules
Develop LC-MS assays, optimized for the biological and non-biological matrix samples of interest. We work with both commercially available drugs and new chemical entities.
Large Molecules
Use of LC-MS assays to quantify therapeutic peptides and proteins for the development of novel therapeutics that include large protein molecules.
Tissue Analysis
Utilize the cutting-edge bead-beater system to homogenize animal, plant and microbiologic samples to quantify extracellular and intercellular concentrations of your compound or metabolites of interest.
Biomarker Measurement
LC-MS assays can measure amino acids and bile acids to support metabolomics and assessment of physiologic changes, particularly helpful for longitudinal assessment of compounds in vivo.
Formulation Analysis
Understand the in vitro stability of your compound based on environmental factors or acceptable excursion standards. Pharmaceutical modifications may help to improve the solubility and stability of your compound in vivo.
Method Development
Access state-of-the art mass spectrometry instruments and technical expertise to meet your low sensitivity and high specificity needs. Our analytical methods are run in accordance with FDA guidance and standards.
Lead Optimization
Working closely with another College core, the Vahlteich Medicinal Chemistry Core, we partner to support lead optimization projects.
Microsomal Stability
Use liver microsomes from animals and humans to compute disappearance rates and predict in vivo clearance, helping you understand the stability of your compound in vivo.
Metabolite Identification
Identify metabolites with LC-MS/MS and various scan modes and fragmentation pathways of the compound. This information guides the synthetic optimization of lead compounds by delineating the metabolic “soft-spots”.
Reaction Phenotyping
Identify the CYP enzymes involved in the metabolism of lead compounds to aid prediction of drug-drug interactions using FDA-recommended inhibitors and recombinant CYP enzymes for confirmation.
CYP Enzyme Induction
Use of real-time PCR assays for CYP expression and test enzymatic activity of induced CYP to understand your compound’s potential for clinical drug-to-drug interactions.
Protein Binding
Utilize in vitro assays such as equilibrium dialysis and ultrafiltration to help you understand the species-specific plasma protein binding.
Blood/Plasma Ratio
Access and use a well-established assay to define the blood-to-plasma ratio that is important for predicting whole-body pharmacokinetics.
Pre-Clinical Studies
Capable of performing oral bioavailability, pharmacokinetic and biodistribution studies in animal models. We have access to facilities at UM In Vivo Animal Core to facilitate healthy disease models for a range of drug discovery and development efforts.
In Vivo Screening
Gain rapid insight into your compound’s behavior in vivo when administered by different routes.
In Vivo PK
Gain broader insights into your compound’s PK profile to support your dose translation in future disease models.
Oral Bioavailability
Understand the oral bioavailability of your compounds to aid in lead selection for further development.
Biodistribution
Ascertain tissue concentration in a specific tissue of interest and into up to 17 different target organs.
Max Tolerated Dose
Understand the acute toxicity of your compound to identify target organs effected and select doses for repeated-dose toxicity studies.
Tumor Model
Gain insight into the disposition and therapeutic effects of drugs essential to dose translation.
Clinical Studies
Assist you in the design of early-phase clinical trials that involve the assessment of exposure-response relationships and collaborate with investigators who access resources offered through UM Institute for Clinical and Health Research.
Study Development
Assist you in the identification of optimal sampling time points, regulatory justification for dose selection, design case report forms, optimal sample matrix and collection tubes, sample processing, storage and handling before bioanalysis.
Data Analysis
Use of non-compartmental analyses for intensive sample data and non-linear mixed effects modeling on sparse sampling sets to characterize systemic exposure and co-model the PK/PD effect or safety of the lead compound.
Modeling and Simulation
Get population-PK analyses and employ parametric or non-parametric approach based on the data. This permits the identification of covariates predictive of system parameters.
Precision Medicine
Utilizing precise mathematical approaches, we design drug-specific Bayesian approach to help you select the right dosage for your patients.