Last Update: 08/17/2006 Printer Friendly Printer Friendly   Email This Page Email This Page  


Pediatric Pharmacology Research Units (PPRU) Network

Pediatric Pharmacology Research Units ImageThe overall approach to drug testing in children, a large patient population, high-quality clinical research, and expertise in pediatric drug studies make the PPRU Network, within the Obstetric and Pediatric Pharmacology Branch, an ideal investigative site for pharmaceutical companies seeking to market drugs with indications for children.

Background

Three-quarters of all medications marketed today do not carry Food and Drug Administration (FDA) approved labeling for use in neonates, infants, children and adolescents. Only five of the 80 drugs most frequently used in newborns and infants are labeled for pediatric use. The FDA has recently made regulatory changes to facilitate labeling of drugs for pediatric use. In 1994 the FDA Center for Drug Evaluation and Research published a Pediatric Plan to encourage studies on pediatric patients during the drug development process.

Three-quarters of all medications marketed today do not carry Food and Drug Administration (FDA) approved labeling for use in neonates, infants, children and adolescents. Only five of the 80 drugs most frequently used in newborns and infants are labeled for pediatric use. The FDA has recently made regulatory changes to facilitate labeling of drugs for pediatric use. In 1994 the FDA Center for Drug Evaluation and Research published a Pediatric Plan to encourage studies on pediatric patients during the drug development process.

A number of therapeutic mishaps have clearly shown that dosing derived from adult studies cannot be extrapolated to infants and children. For many drugs, developmental, metabolic, and pharmacokinetics-pharmacodynamic data are needed for their safe and effective use in children.

In response to the need for appropriate drug therapy for pediatric patients, the NICHD established the Pediatric Pharmacology Research Units (PPRU) Network.

The mission of the PPRU Network is to facilitate and promote pediatric labeling of new drugs or drugs already on the market. In this process the Network strives to foster cooperative and complementary research efforts among academia, industry, and health professionals. The overall goal of the PPRU Network is the safe and effective use of drugs in children. The PPRU Network:

  • Conducts studies on the pharmacokinetics and pharmacodynamics of drugs in children.
  • Provides a locus for pre- and post-marketing clinical trials in children conducted by pediatric clinical pharmacologists in collaboration with the pharmaceutical industry and contract research organizations.
  • Serves as an advisory body to the pharmaceutical industry, regulatory agencies, health professionals and the public on the appropriate use of drugs in children.

Learn more about the PPRU Network:

For information about the PPRU Network, or for information concerning the use of drugs in children please contact George P. Giacoia, M.D.

If you are a researcher and would like to discuss placing a study for labeling purposes, please call Rene C. Kozloff, Ph.D., 1-800-710-8053 or visit http://www.ppru.org.