Facilities
The PPRU is located within the Cincinnati Center for Clinical Research (CCCR), a new 53,500-square-foot facility, operated by Cincinnati Children's Research Foundation and dedicated to the support of clinical research trials. The CCCR was created to support both pediatric (Phase I – IV) and adult (Phase I – III) clinical research studies. It is the first and only facility of its kind in the Tri-state. The CCCR includes facilities for outpatient studies (pediatric and adult), as well as extended-stay studies (adults only). Other features available are: onsite lab processing, secured investigational onsite pharmacy, phlebotomy rooms, study coordinator workspace, DEXA, and much more.
In addition to the CCCR, Cincinnati Children's General Clinical Research Center (GCRC) is used for inpatient and outpatient studies. The newly renovated GCRC inpatient facilities include an 8,400-square-foot unit containing eight beds, two treatment rooms, a small kitchen, and offices for the staff. The outpatient unit includes a 2,500-square foot area with seven examination rooms that are contiguous to GCRC inpatient and laboratory space. A full staff of nurses experienced in clinical research in children is available to execute PPRU nursing protocols performed on the GCRC.
PPRU Laboratory
An integral part of the PPRU is the Laboratory of Applied Pharmacokinetics and Therapeutic Drug Monitoring (LAP-TDM). The laboratory supports Phase I/II trials and investigator-initiated research in the field of applied pharmacokinetics and pharmacodynamics (PK-PD) through drug analyses in blood and other body and data interpretation and analysis.
The LAP-TDM is a Center of Excellence for Population PK-PD Modeling and simulation. Available software packages includes: Pharsight's WinNonlin WinNonmix, and TrialSimulator (Pharsight, Mountain View, CA), NONMEM, PDxPop (Globomax, Hanover, MD), NPEM/NPAG (USC, CA), simulation programs (Edsim, ADAPT) and Bayesian dose optimization programs for clinical applications (USCPACK, MW/PHARM).
In addition, the LAP-TDM group is actively engaged in analysis and interpretation of drug levels using population modeling techniques and Bayesian adaptive control. Drug level consultation is provided through the Division. Current assay development includes immunosuppressive drugs (sirolimus, tacrolimus and mycophenolic acid), protease inhibitors, amantadine, and enantio-selective analysis of risperidone and metabolites.
The lab utilizes state of the art equipment including Agilent Automatic Liquid and High Performance Liquid Chromatography (HPLC) systems and Abbott's TDx-FLx and IMx. The lab is in the process of acquiring its own tandem LC-MS equipment, scheduled for the second half of 2004. There is access to two LC/Mass Spectrometry instruments for assay methods development and drug analysis through the core Mass Spectrometry Lab. The laboratory is CAP certified and is working towards GLP accreditation and certification.
The Pediatric Pharmacology Research Unit staff occupies a suite of offices, approximately 2,500-square feet in close proximity to the laboratory. Secretarial assistance and access to word processing, data analysis and storage software are available on network computers.
Contact Us
For more information about the Pediatric Pharmacology Research Units, please contact Dr. Alexander Vinks, 513-636-0159, sander.vinks@cchmc.org.
