Clinical Pharmacology Unit
The CPU provides services to university investigators and the pharmaceutical industry based on a fee schedule. The unit aids in the design, evaluation and optimization of clinical trials. CPU faculty share their knowledge of drug-drug interactions, drug administration methods and dosage forms, as well as disease conditions, clinical effects and toxicity. They conduct an array of highly sensitive laboratory assays. The CPU consults on trial design improvements and dosing schemes to determine the efficacy and safety of an experimental compound.
Clinical pharmacologist and researchers Kenneth Bauer, PharmD, PhD, associate professor, and Thomas Dowling, PharmD, PhD, associate professor, to build a National Institutes of Health- approved recharge center which captures income while sharing unique expertise. School of Pharmacy scientists James Polli, PhD, and Natalie D.Eddington, PhD, are collaborators and faculty associates in the CPU.
CPU faculty work with clients to advance safe and useful products through Food & Drug Administration (FDA) procedures. Bauer and Dowling provide regulatory advice and direction to CPU clients to ensure that their requests to the FDA meet regulatory requirements. CPU faculty also serve as collaborators in laboratory and animal studies to test how drugs work in cells, organs and systems such as the liver and kidneys.
Research Capabilities
The Clinical Pharmacology Unit Lab is capable of:
- Conducting Renal Function Studies (GFR and ERPF) for baseline and post-intervention periods in a variety of patient populations including chronic kidney disease, heart failure, and liver disease;
- Developing laboratory assays to test drug plasma concentrations, intermediate biomarkers and Clinical Trial clinical endpoints. (non-GLP);
- Conducting the validated assay on samples provided by Industry to test the absorption, distribution, metabolism, and elimination of the drug in the Clinical Trials subjects; and
- Employing targeted in vitro and in vivo animal study techniques to test cell uptakes, transport, liver metabolism, and animal pharmacokinetic distribution and toxicology as surrogate studies in the preclinical examination of the compound prior to human testing.
Research Services
The Clinical Pharmacology Unit offers:
- Expertise in drug administration and drug-drug interactions resulting in recommendations aimed at maximizing the response and minimizing toxicity to the compound.
- Information specific to the compound’s administration routes, dosage, dose administration times, and concomitant medications with due consideration of clinical effect, disease condition, clinical toxicity, and the proposed biologic response markers.
- Ability to offer recommendations on optimal time points to test each compound’s effectiveness, efficacy and safety in administering the compound to humans.
- Models for testing and projecting the drug pathway based on the concomitant drugs and the disease state.
- Data analysis and reporting of the Pharmacokinetics of the compound(s) based on clinical trial intermediate and clinical outcomes data.
- Scientific analysis of Pharmacodynamic Reports about the compound(s) and results for application to the Clinical Trial design and clinical results.
- Design pharmacogenetic assessments for Clinical Trials, and provide analysis of genotype and phenotype marker compounds.
- Evaluate and report Industry-provided clinical trial data using advanced data analysis techniques.
- Clinical trial outcome simulations based on the data provided by the Industry.
- Pharmacometric modeling to clinical pharmacology studies to better inform the anticipated human-drug interaction.
- Reports and publications on data analyses as requested.
- Preparation of Clinical Pharmacology sections of the Food & Drug Administration recommendations for Investigational New Drugs and New Drug Applications, and Investigator Brochures.
- Clinical Pharmacology expertise to investigators in academia and in industry.