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Continuing Medical Education from AAP helps you stay current in practice and provides tools and resources for every stage of your career. The Pediatric Clinical Trials Database summarizes pediatric clinical trials submitted in response to pediatric legislative initiatives that resulted in new pediatric labeling.
New drug development should be as efficient as possible, particularly in pediatric drug development when the available patient population is relatively small and has special vulnerabilities. The extrapolation of efficacy from adult and other data to the pediatric population minimizes the exposure of children to clinical trials, increases the speed and efficiency of pediatric drug development and allows pediatric patients timely access to safe and effective medicines.
The FDA Pediatric Study Decision Tree Figure 1 provides a simple assumptions-based framework that can be a helpful starting point in determining the pediatric studies excluding oncology studies necessary for labeling based on the ability to extrapolate efficacy from adult or other data. If the assumptions required for extrapolation do not apply Option A, Figure 1 , then extrapolation cannot be used and efficacy must be demonstrated independently in the pediatric population by conducting two adequate and well-controlled trials.
Pediatric pharmacokinetic PK studies should be conducted by using adult PK data to establish the correct dose for the condition or disease of interest. In some cases, pharmacokinetic modeling may be helpful to select the range of doses to be used in the studies. A crucial factor in designing pediatric efficacy studies is that the clinical endpoints must be age and developmentally appropriate and validated for use in the pediatric age group under study.
Fever was often found to be the primary or only A new report describes the clinical Using a novel technique, researchers have been able What Makes Us Human? Stem cell researchers have now found a previously overlooked They report Rotavirus vaccines for children in developing countries: understanding the science, maximizing the impact, and sustaining the effort.
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