The FDA released new draft guidance outlining the clinical pharmacology, ethical and trial design factors that should be considered by drug developers when planning to conduct clinical trials of drugs and biologics in a pediatric population. "The measurement or prediction of a drug's pharmacokinetics (exposure) and pharmacodynamics (response) is essential to the clinical pharmacology assessment," the agency noted, adding that "[i]t is important to describe the exposure-response relationship of a drug in the pediatric population when possible to enhance the understanding of effective dose ranges or support the ability to extrapolate information from older pediatric participants."