The University of Toledo

CD3 - Clinical Research Facilities

Facilities for the performance of clinical studies include two major medical centers in the metropolitan Toledo area [The Toledo Hospital (TTH), St. Vincent Mercy Medical Center (SVMMC)], along with UT’s Health Science Campus (HSC), two outpatient clinics, and the offices of a number of collaborative physicians. Collectively, the facilities provide access to over 1,700 patient beds representative of all major subspecialties, approximately 40,000 outpatient exposure and over 1,000 patients per year with oncologic diagnosis.

Specific areas of clinical research and practice for the CD3's network are largely coordinated through, or are conducted in close conjunction with, the HSC, which specializes in entertaining clinically oriented Phase I, II and IV studies. A multi-disciplinary Phase III site is afforded through interactions with TTH. Clinical investigator's interests encompass, but are not limited to, infectious disease, cardiology, critical care, nutrition, and oncology. Outpatient facilities for research include resources for studies in "normal" volunteers, as well as in disease-specific patient populations. There are particular clinical research interests in pharmacokinetic characterization in normal healthy subjects and in defined patient groups. These may be extended to bioavailability, pharmacokinetic and pharmacodynamic modeling, and drug interaction studies.

Physicians collaborating with the Center's clinical investigators provide physical assessment and diagnostic services. Skilled nurses experienced in the conduct of clinical drug trials participate as part of the research team. Performance of clinical laboratory measurements are conducted by certified laboratories at each of the affiliate medical centers or within the CD3 program in bioanalytical chemistry. Laboratory space and equipment for conducting experimental analytical work and pre-clinical trials are available at the University and through cooperative efforts at the toxicology laboratory at HSC. Computer analyses are provided using mainframe or microcomputers available on campus.

The University complies with all HHS requirements for the use of human subjects experimentation and works cooperatively with the institution review boards of the affiliate institutions.

Laboratory space and equipment at The University of Toledo are well-suited for conducting biopharmaceutical-related analytical work. Measurements of drug and metabolites in biological samples can be performed using fluorescence polarization immunoassay (FPIA), gas chromatography (GC) and high pressure liquid chromatography (HPLC). The analytical facilities of the toxicology laboratory at MCO add a GC-mass spectroscopy (GC-MS) capability and the CD3's extended network provides for HPLC-MS and HPLC-MS/MS studies.