OPPTB Research Programs

Branch Research Focus and Mission

Multiple knowledge gaps regarding the use of therapeutics in children and pregnant and lactating women have resulted in inadequate labeling and frequent off-label use of prescription drugs in these populations. NICHD and, in particular, OPPTB supports pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenomic (PG) research on medications for children and pregnant and lactating women to help ensure their safety and usefulness for preventing, treating, and managing diseases and disorders.

Specific areas of interest within pediatric and pregnant and lactating populations include:

  • Developmental pharmacology and toxicology
  • Development of formulations and devices appropriate for pediatric use
  • Safety and PK studies
  • PD studies
  • PG and personalized medicine
  • Identification of molecular targets and development of targeted medications in diseases that affect populations of interest
  • Identification of biomarkers appropriate for pediatric use
  • Innovative study designs for small populations
  • Preclinical and nonclinical models of drug disposition and effect
  • Mechanisms of drug effects (efficacy and safety)
  • Mechanisms of changes in PK and PD over time, including throughout gestation and childhood development
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