Extrapolation of adult data and other data in pediatric drug-development programs.

  title={Extrapolation of adult data and other data in pediatric drug-development programs.},
  author={Julia Dunne and William J. Rodriguez and Mary Dianne Murphy and Bach Nhi Beasley and Gilbert J. Burckart and Jane D. Filie and Linda L. Lewis and Hari Cheryl Sachs and Philip H. Sheridan and Peter R Starke and Lynne P. Yao},
  volume={128 5},
OBJECTIVES In 1994, the US Food and Drug Administration (FDA) proposed an approach, based on extrapolation of efficacy findings from adults to the pediatric population, to maximize the use of adult data and other data when designing pediatric drug-development programs. We examined the experience of the FDA in using extrapolation to evaluate how and when it was used and any changes in scientific assumptions over time. METHODS We reviewed 370 pediatric studies submitted to the FDA between 1998… CONTINUE READING
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