Drug Metabolism and Pharmacokinetics (DMPK)
Our drug metabolism and pharmacokinetics (DMPK) group offers a comprehensive selection of in vivo and in vitro DMPK services to help clients manage their drug discovery and development programs. Our highly trained scientific staff offer both standard regulatory-driven study designs and innovative approaches to unique drug development issues. Our senior scientists each have over 20 years of experience as study directors and principal investigators, and several are adjunct faculty at North Carolina universities. The primary focus of the DMPK group is to provide our clients with the highest quality studies and reports along with expert consultation.
In Vivo Capabilities
- GLP-compliant or non-GLP studies
- Pharmacokinetic studies in standard biological models
- Pharmacokinetic modeling (classically and physiologically based)
- Discovery pharmacokinetic screening
- Oral and percutaneous bioavailability studies
- Radiolabeled studies
- Tissue distribution and mass balance studies
- Drug-drug interactions (induction and inhibition)
- Metabolite profiling and metabolite identification
- Biomarkers of exposure (hemoglobin and DNA adducts)
- In situ and isolated perfused organs (kidney, liver, intestine)
- Specialized cannulations (vascular, biliary, and lymphatic)
In Vitro Capabilities
- CYP inhibition (reversible and mechanism-based)
- CYP induction (with optional cytotoxicity, mRNA expression, and Western blots)
- CYP reaction phenotyping (HLM or rhCYPs)
- Intestinal permeability in Caco-2 cells (Pgp substrate and/or inhibitor)
- Metabolite profiling and identification in hepatocytes or microsomes
- Metabolic stability in hepatocytes or microsomes
- Protein binding (equilibrium dialysis)
- Cytotoxicity in hepatocytes (necrotic or apoptotic)
- Endocrine disruptor tier 1 screens (estrogen receptor binding, aromatase inhibition)
Analytical Capabilities
- HPLC with UV, fluorescent, electrochemical, and radiometric detection
- Agilent 1100 and 1200 autosamplers
- UPLC
- LC/MS/MS (API 3000, 2 API 4000s, and API 5000)
- API 4000 QTrap
- GC/MS, and GC with EC and FID detection
- Preparative HPLC
- 300 and 500 MHz nuclear magnetic resonance spectrometers
- LC-TOF MS
Additional Resources
- DEA Schedule 1 Certificate
- AAALAC-accredited facilities (vivarium)
- Consultation services