The PPRU Network is Unique

Pediatric pharmacology is our sole concern. The integration of state-of-the-art pediatric pharmacology units allows us to perform pediatric clinical trials in a cost-effective and time-expedient manner.

• The PPRU team of pediatric pharmacologists, research coordinators and patient recruiters is primarily concerned with the special needs of children.
• The Eunice Kennedy Shriver National Institute of Child Health and Human Development is recognized throughout the world for its expertise in conducting multi-center clinical trials in pediatric patients, from premature infants to adolescents.
• An extensive network of pediatric subspecialty investigators work together with pediatric pharmacologists to carry out studies of drug therapy over a wide range of pediatric diseases.
• Experts in pediatric pharmacokinetics provide the industry with accurate information for dose requirements and drug disposition in children of all ages.

Commitment to pediatric labeling and our expertise in pediatrics make the PPRU Network uniquely qualified to advise the pharmaceutical industry on the adequacy of adult studies on drug efficacy and safety for extrapolation to pediatric patients and on whether additional pharmacokinetic studies are needed to support labeling.

The PPRU Network can also identify pediatric diseases in need of new drugs, new indications for already marketed drugs, and better means to analyze existing data to meet FDA labeling requirements.

• Bioavailability and bioequivalence
• Developmental pharmacogenetics
• In-vitro assessment of metabolite-mediated cellular injury
• Pharmacokinetics modeling
• Pharmacodynamic

• Hospital inpatient studies
  (includes patients in neonatal intensive care units and pediatric intensive care units)
• Ambulatory care studies

• Post-marketing study designs

• Small volume sample drug and metabolites analysis
• Core molecular pharmacology laboratory
• Antiviral drugs assays

• Behavioral medicine
• Cardiology
• Endocrinology
• Gastroenterology
• Infectious diseases
• Hematology
• Hypertension
• Immunology/allergy
• Inmunopharmacology
• Metabolism
• Neurology
• Pain management
• Oncology
• Nephrology
• Pulmonology
• Psychiatry

The PPRU Network is governed by a Steering Committee which consists of the principal investigators of each of the seven units and a representative from the NICHD. The Steering Committee is chaired by an independent investigator. An FDA liaison serves as a consultant and advises members on regulatory issues.

The Steering Committee evaluates protocols for scientific merit and serves as an advisory board for issues concerning pediatric labeling and appropriate use of drugs in children.

Each of the PPRUs includes:

• A Principal Investigator (PI) responsible for developing and maintaining the PPRU and for conducting research within the Unit.
• A team of pharmacologists and clinical investigators representing all subspecialties of pediatrics.
• Other specialists in clinical trials such as a nurse coordinator, an associate clinical pharmacologist, and a data coordinator.
• A core analytical and biomedical laboratory which provides state-of-the-art study design, computer modeling of drug disposition and drug response, and data management and analysis.