Note: This network is complete. The information on this page is provided for historical purposes only, and serves as a bridge to the PPRU datasets. The page is not being updated.
NICHD established the PPRU Network in 1994 to facilitate and promote pediatric labeling of new drugs or drugs already on the market by fostering cooperative and complementary research efforts among academia, industry, and health care providers. The PPRU Network ended in 2010. This information is intended for reference and historical purposes.
The PPRU Network was initially housed within NICHD’s Endocrinology, Nutrition, and Growth Branch (now the Pediatric Growth and Nutrition Branch) until 2004, when the Obstetric and Pediatric Pharmacology and Therapeutics Branch was created.
Between 1994 and 2008, as the PPRU Network grew from 7 to 13 sites at universities and children's hospitals, its focus broadened as well. Initially, the PPRU Network's priority was to conduct clinical trials that would lead to pediatric labeling of pharmaceuticals that were commonly used off-label to treat children. PPRU researchers also contributed to advances in pediatric research through the development and validation of new basic and preclinical research models, biomarkers, study designs, and drug-delivery systems.
Later, the network pursued a program in developmental and pediatric clinical pharmacology that included basic and translational research—such as patient-oriented therapeutics and drug response studies—on pharmaceuticals. The network encouraged efficient and effective use of its data through the PPRU Clinical Data Repository, which stored all investigator-initiated study data using a common set of terms and definitions, allowing data sharing and metadata analysis. The network also trained new investigators in pediatric pharmacology.
Activity in the PPRU Network continued until 2010.
The PPRU Network:
- Conducted studies on the pharmacokinetics and pharmacodynamics of drugs in children
- Provided a home for pre- and post-marketing clinical trials in children conducted by pediatric clinical pharmacologists in collaboration with the pharmaceutical industry and research organizations
- Served as a pediatric clinical trials information resource for the pharmaceutical industry, regulatory agencies, health care providers, and the public on the appropriate use of drugs in children
Network activities included: Preclinical and Phase I studies, such as bioavailability and bioequivalence, developmental pharmacogenetics, in vitro assessment of metabolite-mediated cellular injury; pharmacokinetics modeling, and pharmacodynamics; Phase II and III studies, such as hospital inpatient studies and ambulatory care studies; and Phase IV studies, such as post-marketing study designs, laboratory/assay specialization, small volume sample drug and metabolites analysis, core molecular pharmacology laboratory, and antiviral drugs assays.
Studies addressed many therapeutic categories, including: behavioral medicine, cardiology, endocrinology, gastroenterology, infectious diseases, hematology, hypertension, immunology/allergy, immunopharmacology, metabolism, neurology, pain management, oncology, nephrology, pulmonology, and psychiatry.
- NICHD Contact: George Giacoia