Pediatric Study Plan (PSP)

  • An Initial PSP is an outline of the pediatric study or studies that the drug development sponsor plans to conduct in the USA – to confirm the suitability of drug usage in the pediatric population.
  • Initial PSPs cover study objectives and design, age groups, relevant endpoints and statistical approach. Amended PSPs follow.
  • The preparation of a PSP requires concise presentation of information about the disease to be treated in children, as well as laying out all relevant current knowledge of the drug being developed, assembling a convincing rationale for the pediatric study plan proposed.
  • Trilogy staff have accumulated extensive experience in the preparation of plans covering a range of pediatric therapeutic areas.
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