Founded: 1978
Full Time: 7
Part Time: 1
Budget: 359,512.00
Director: Professor John T. Wilson, M.D.
1501 Kings Highway, P.O. Box 33932
Shreveport, LA 71130-3932
Telephone: 318/675-5080 FAX: 318/675-7845E-Mail: jwilso1@lsuhsc.edu
Research Areas:
The Section undertakes disparate activities to broaden our knowledge about the safe and effective use of drugs in children . The Section is a founding site of the 13-member Pediatric Pharmacology Research Unit (PPRU) network, now in its tenth year of funding by the NIH.
As described below, multiple facilities and tasks are integrated to meet our mission:
To improve the lives of children through clinical pharmacology research.
Goals of the Section include:
1. Maintain a child friendly staff and environment for
pediatric clinical trials
2. Perform innovative translational research
3. Undertake training and education
4. Improve the application of pharmacotherapy to patient care,
especially children.
A primary facility of the Section is the Children's Clinical Research Center (CCRC). It is an academic pediatric pharmacology research unit staffed by pediatric nurses and LSUHSC faculty members from the Department of Pediatrics, Section on Clinical Pharmacology.
The CCRC performs approximately 30 clinical trials annually, both industry-sponsored and investigator-initiated. The 4-bed CCRC unit, located adjacent to the pediatric wards at LSUHSC, is staffed by trained, research-certified nurses and staffed 24/7. Dr. John T. Wilson, Section Chief and Principal Investigator, is jointly appointed as Professor of Pediatrics and Psychiatry and has been active in pediatric pharmacology for many years, with publications in major journals and in several textbooks. Dr. Ann Springer, Clinical Assistant Professor of Pediatrics and Psychiatry, has served as principal investigator for several industry-sponsored clinical trials and has authored several investigator-initiated protocols. The unit has expertise in clinical trials producing data on pharmacokinetics, pharmacodynamics, safety, and efficacy, as well as translational science. Strong collaborative relationships with subspecialists in pediatrics and adult medicine, as well as with basic scientists within the university system, have led to the development of multidisciplinary research projects. The Core Laboratory of the unit has capabilities that foster drug formulation development. The lab provides analytical methods for drug and metabolite levels in samples from clinical studies, for specific immunoassays of surrogate markers such as cytokines and growth factors, and for CYP450 subform phenotyping. The core laboratory also coordinates with other laboratories to develop methods and standardize procedures for protocols. The laboratory director, Virginia Johnson MS, is a biochemist with a particular expertise in the analytical aspects of clinical pharmacology. She has considerable expertise in the area of Good Laboratory Practice (GLP) and drug development, including the submission of INDs and NDAs for industry. Major equipment housed in the core laboratory includes:
For Chemical Separation and analysis: Hewlett-Packard Model 1090 High Pressure Liquid Chromatograph with Diode Array Detector, Hewlett-Packard Series 1100 Mass Spec Detector, Hewlett Packard Model 1100 High Pressure Liquid Chromatograph with Fluorescence Detector, Hewlett Packard 1049A Programable Electrochemical Detector
For Sample Preparation and Storage: IEC Centra MP4 and CL3R Refrigerated Centrifuges, sealed swinging bucket rotors, VWR Model 5466 Ultralow Freezer.
Research interests of the unit include diabetes types I & II; neurodevelopmental and behavioral medicine, particularly involving fetal alcohol syndrome and ADHD; pharmacogenomics of cytochrome P450; antidepressants; anticonvulsants; anti-infectives; antipyretics; analgesics; antihypertensives; and vaccine research. Available resources for research in these areas include neuroimaging, sleep laboratory, and both neonatal and pediatric intensive care units. Compliance is maintained for clinical research guidelines of the NIH, FDA, IRB and other relevant federal and private agencies. Monitoring of protocols is undertaken by the NIH (Data Safety Monitoring Board) for investigator initiated studies and by respective pharmaceutical companies for sponsored studies.
The Section performs its many tasks of research, teaching and patient care by use of a matrix business plan. For this, responsibilities are delegated to leaders in modules of Research, Analytical Laboratory, Teaching, Clinical Care, Regulatory Affairs, and Administration. Performance criteria and outcomes are reviewed on a weekly basis, and both quarterly and annual reports of research findings are submitted to the NIH.
The Section offers a resource to the LSU System by virtue of its nationally recognized contributions to safety and efficacy of drugs for children.
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Areas of Expertise:
Pharmacokinetic/Pharmacodynamic analysis, mathematical modeling of cyclic functions, studies of the plasma protein binding of drugs, metabolic routes and rates of drug disposition, experimental design and statistic analysis.
Special Capabilities and Facilities:
The core laboratory provides analytical support for the Pediatric Pharmacology Research Unit and other research projects. Staff members perform method development and analyses for drug studies and review protocols to identify necessary analytical techniques, in addition to specifying their availability and cost.
The core laboratory now includes one 940 square foot space and two additional laboratory spaces, each of approximately 400 square feet. One of the smaller laboratories is equipped and maintained for the purpose of assisting investigators who are directly involved in laboratory aspects of their protocols. The larger facility, the core laboratory itself, houses the major pieces of analytical equipment, along with support equipment for sample preparation. HPLC-MS analytical methods are applied to drug investigation.
The Children's Clinic Research Unit is being expanded to 3-4 beds for clinical trials and other research of the department.
Research Equipment:
HPLC
HPLC-MSD
Keywords:
0710005 Adolescent Health
0710030 Biomedical Research, Multidisclipinary
0710040 Chemistry, Clinical
0710045 Drug Metabolism
0710100 Pharmacology
0710136 Pharmacoeconomics
0715006 Adverse Effects
0730005 Child/Maternal Health
0740080 Dosage Forms
0740081 Drug Delivery Systems
0740084 Pharmacokinetics
0755010 Bioassay
0755015 Clinical Trial
0755018 Data Management/Analysis
0755060 Screening of Drugs/Agents
0755065 Mathematical Modeling (Medical)
0755066 Methods of Drug Delivery
0765020 Metabolism
0770005 Children (Patients)
0783005 Human Subjects Policy
0785015 Anesthesiology
0785170 Pediatrics
0785185 Pyschiatry
1004016 Data Analysis
1004043 Computer Simulation/Modeling
1014011 Laboratory Practice/Procedure