Medical & Scientific Communications 2015 Annual Forum

Pediatric Investigation Plans (PIP) ensure that the necessary data are obtained through studies in children to support the authorization of pediatric medicines. The normal development of any medicine requires that studies be performed to ensure its quality, safety, and efficacy in subjects. PIPs must include elements that are similar or different from adults (disease state, safety and efficacy), a robust dose selection strategy, formulation plans, studies with clear end points and other specific elements tailored to the pediatric population. These pediatric investigation plans are dynamic documents which may change over the course of product development and include modifications in study design and timeline implementation. Without evidence-based information and appropriate pharmaceutical formulations to support administration of many medicines in children, pediatricians may elect to use off-label or unauthorized products, which can result in unnecessary and unwanted side effects or little efficacy.