The University of Toledo

Center for Applied Pharmacology

About CAP

The Center for Applied Pharmacology is a consortium of academic and hospital-based investigators with major interests in the relationship between drug disposition and drug dynamics. The Center was founded through the joint efforts of The University of Toledo and St. Vincent Medical Center in December, 1990.

The Center for Applied Pharmacology conducts clinical investigations pertaining to:

• pharmacokinetics and pharmacodynamics in normal healthy subjects and in defined patient Groups
• bioavailability
• pharmacokinetic/pharmacodynamic modeling
• population kinetics
• drug interactions
• characterization of IND effects on human cytochromes P450 in vitro and in vivo

Center personnel are specialized in theoretical and applied pharmacokinetics, drug metabolism and disposition, and drug utilization review. Support personnel include various medical specialists, experienced clinical pharmacists, research nurses, and laboratory technologists.

Projects recently completed at CAP

• The influence of dirithromycin on the pharmacokinetics of cyclosporine in healthy subjects and in renal transplant patients.
• Astudy of the interaction between theophylline and LTD4 inhibitor, MK0476.
• Controlled study of the putative interaction between famotidine and theophylline in COPD patients.
• Absence of an inhibitory effect of omeprazole and nizatidine on phenytoin disposition, a marker of CYP2C activity.
• Acomparative study of the interaction between antacid and H-2 receptor antagonists.
• Drug interactions of H-2 receptor antagonists.
• Bioavailability study of nizatidine when administered in food.
• Astudy of the interaction between dirithromycin and astemizole in healthy adults.
• Astudy of the interaction between azithromycin and cyclosporine in renal transplant patients.
• Several studies of the interaction between selective COX2 inhibitors and methotrexate in patients with rheumatoid arthritis

Facilities

The Center for Applied Pharmacology has facilities in Toledo, Ohio. Laboratory space and equipment at the University of Toledo are currently available for conducting analytical work. Measurements of drugs and metabolites in biological samples con be performed using fluorescent polarization immunoassay (FPIA), gas chromatography (GC), and high performance liquid chromatography (HPLC). Through a strategic alliance agreement virtually any type of analytical work including LC/MS/MS can be undertaken at the comprehensive laboratories of Ricerca, LLC, which is a GLP certified laboratory.

Physical examinations are performed by M.D.s and clinical laboratory measurements are performed by the certified laboratory at St. Vincent Medical Center. The Medical Center is also the inpatient and outpatient performance site for drug administration, drug sampling, and subject observation. Skilled nurses experienced in the conduct of clinical drug trials participate fully throughout each investigation. Computer analyses can be performed using conventional pharmacokinetic and statistical software operating on either the University of Toledo mainframe computers or microcomputers. Studies are not initiated without approval from the Human Subjects Committees of cooperating institutions.

Reports

Results of clinical investigations are provided in a timely manner. Copies of all records are maintained on file by The Center for Applied Pharmacology, and are available for audit by appropriate Institutional Review Boards and sponsors.

References to specific subjects or patients are codified so that identities always remain confidential. Manuscripts intended for publication will be sent to contractors prior to journal submission as a matter of courtesy. The suitability of data for publication is an issue which must be negotiated and agreed to prior to the initiation of any investigation by The Center for Applied Pharmacology.

Costs

The Center for Applied Pharmacology is an academically oriented consortium of investigators interested in conducting clinical investigations of pharmacokinetic and pharmacodynamic interest. It is interested in conducting such investigations cost- effectively. Each project budget is negotiated separately, but basically The Center for Applied Pharmacology will charge only enough to recover costs for supplies, clinical personnel, laboratory tests, physical examinations, and technical help. A modest overhead charge will be added. For extensive projects some salary offset of a principal investigator may be necessary.